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    Clinical Trial Results:
    A Phase 3, Multicenter, Four-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy And Safety Trial Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Current Or Most Recent Episode Manic)

    Summary
    EudraCT number
    		 2020-003972-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Dec 2020
    First version publication date
    02 Dec 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A1281198
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02075047
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Aug 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of oral ziprasidone compared with placebo in the treatment of children and adolescents aged 10-17 with Bipolar I Disorder (current or most recent episode manic) as measured by the change from baseline to Week 4 in the Young Mania Rating Scale (YMRS) total score. To evaluate the safety and tolerability of oral ziprasidone over 4 weeks in the treatment of children and adolescents with Bipolar I Disorder (current or most recent episode manic).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 May 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 170
    Country: Number of subjects enrolled
    Ukraine: 1
    Worldwide total number of subjects
    171
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    39
    Adolescents (12-17 years)
    132
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was conducted in the United States and Ukraine. Study started on 23 May 2014 and completed on 18 May 2020. Total 171 subjects were randomised to treatment, of which 86 received investigational product.

    Period 1
    Period 1 title
    Treatment Phase (4 Weeks)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Carer, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ziprasidone
    Arm description
    		 Subjects were randomised to receive ziprasidone capsules orally once daily for 4 weeks. Dose was titrated over the first 7-14 days of treatment, and the stable dose was maintained for remaining treatment period. Subjects with body weight less than 45 kilogram (kg) received 60 to 80 milligram per day (mg/day) and subjects with body weight greater than or equal to (>=) 45 kg received 120-160 mg/day, as per investigator discretion. Subjects after completion or discontinuation of treatment were eligible to enroll in open label extension study A1281201 or were followed-up to 35 days (5 weeks) after last dose in this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ziprasidone
    Investigational medicinal product code
    CP-88,059-1
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received ziprasidone capsules orally once daily for 4 weeks. Subjects with body weight less than 45 kg received 60 to 80 mg/day and subjects with body weight >=45 kg received 120-160 mg/day.

    Arm title
    		 Placebo
    Arm description
    		 Subjects were randomised to receive placebo capsules matched to ziprasidone once daily for 4 weeks. Subjects after completion or discontinuation of treatment were eligible to enroll in open label extension study A1281201 or were followed-up to 35 days (5 weeks) after last dose in this study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Ziprasidone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo capsules matched to ziprasidone daily for 4 weeks.

    Number of subjects in period 1
    		Ziprasidone Placebo
    Started
    86
    85
    Completed
    63
    75
    Not completed
    23
    10
         Screen Failure
    1
    -
         Adverse event, non-fatal
    14
    4
         Withdrawal By Parent/Guardian
    4
    2
         Medication Error Without Associated Adverse Event
    1
    -
         Unspecified
    1
    1
         Lost to follow-up
    -
    1
         Lack of efficacy
    2
    2
    Period 2
    Period 2 title
    Follow up Phase (5 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ziprasidone
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Ziprasidone Placebo
    Started
    63
    75
    Completed
    60
    72
    Not completed
    26
    13
         Screen Failure
    1
    -
         Adverse event, non-fatal
    14
    4
         Withdrawal By Parent/Guardian
    7
    4
         Medication Error Without Associated Adverse Event
    1
    -
         Unspecified
    1
    2
         Lost to follow-up
    -
    1
         Lack of efficacy
    2
    2
    Joined
    23
    10
         Continued to follow up
    23
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ziprasidone
    Reporting group description
    		 Subjects were randomised to receive ziprasidone capsules orally once daily for 4 weeks. Dose was titrated over the first 7-14 days of treatment, and the stable dose was maintained for remaining treatment period. Subjects with body weight less than 45 kilogram (kg) received 60 to 80 milligram per day (mg/day) and subjects with body weight greater than or equal to (>=) 45 kg received 120-160 mg/day, as per investigator discretion. Subjects after completion or discontinuation of treatment were eligible to enroll in open label extension study A1281201 or were followed-up to 35 days (5 weeks) after last dose in this study.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomised to receive placebo capsules matched to ziprasidone once daily for 4 weeks. Subjects after completion or discontinuation of treatment were eligible to enroll in open label extension study A1281201 or were followed-up to 35 days (5 weeks) after last dose in this study.

    Reporting group values
    		 Ziprasidone Placebo Total
    Number of subjects
    		 86 85 171
    Age Categorical
    Units: Subjects
        Children (10-11 years)
    		 23 16 39
        Adolescents (12-17 years)
    		 63 69 132
    Gender Categorical
    Units: Subjects
        Female
    		 48 47 95
        Male
    		 38 38 76
    Race Characteristics
    Units: Subjects
        White
    		 59 55 114
        Black or African American
    		 23 24 47
        Asian
    		 1 1 2
        Other
    		 3 5 8
    Ethnicity Characteristics
    Units: Subjects
        Hispanic or Latino
    		 12 14 26
        Not Hispanic or Latino
    		 74 71 145

    End points

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    End points reporting groups
    Reporting group title
    Ziprasidone
    Reporting group description
    		 Subjects were randomised to receive ziprasidone capsules orally once daily for 4 weeks. Dose was titrated over the first 7-14 days of treatment, and the stable dose was maintained for remaining treatment period. Subjects with body weight less than 45 kilogram (kg) received 60 to 80 milligram per day (mg/day) and subjects with body weight greater than or equal to (>=) 45 kg received 120-160 mg/day, as per investigator discretion. Subjects after completion or discontinuation of treatment were eligible to enroll in open label extension study A1281201 or were followed-up to 35 days (5 weeks) after last dose in this study.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomised to receive placebo capsules matched to ziprasidone once daily for 4 weeks. Subjects after completion or discontinuation of treatment were eligible to enroll in open label extension study A1281201 or were followed-up to 35 days (5 weeks) after last dose in this study.
    Reporting group title
    Ziprasidone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4

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    End point title
    		 Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4
    End point description
    YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania. Intent-to-treat (ITT): all randomised subjects who had baseline measurements, took at least 1 dose of study medication (ziprasidone or placebo) and with at least 1 post-baseline visit.
    End point type
    Primary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    85
    83
    Units: units on a scale
        least squares mean (standard error)
    -16.51 ( 1.15 )
    -12.29 ( 1.10 )
    Statistical analysis title
    		 Change at Week 4
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in least square (LS) mean
    Point estimate
    -4.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.14
         upper limit
    		 -1.32
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.47

    Secondary: Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4

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    End point title
    		 Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4
    End point description
    CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill), higher scores indicated more severity of illness. ITT population included all randomised subjects who had baseline measurements, took at least 1 dose of study medication (ziprasidone or placebo) and with at least 1 post-baseline visit.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 3, 4
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    85
    83
    Units: units on a scale
    least squares mean (standard error)
        Change at Week 1
    -0.91 ( 0.10 )
    -0.47 ( 0.10 )
        Change at Week 2
    -1.13 ( 0.12 )
    -0.91 ( 0.12 )
        Change at Week 3
    -1.53 ( 0.13 )
    -1.14 ( 0.13 )
        Change at Week 4
    -1.59 ( 0.14 )
    -1.32 ( 0.14 )
    Statistical analysis title
    		 Change at Week 1
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.69
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13
    Statistical analysis title
    		 Change at Week 2
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.174
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.53
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    		 Change at Week 3
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.024
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.71
         upper limit
    		 -0.05
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.17
    Statistical analysis title
    		 Change at Week 4
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.138
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.64
         upper limit
    		 0.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.19

    Secondary: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 1, 2, and 3

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    End point title
    		 Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 1, 2, and 3
    End point description
    YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania. ITT population included all randomised subjects who had baseline measurements, took at least 1 dose of study medication (ziprasidone or placebo) and with at least 1 post-baseline visit.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 3
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    85
    83
    Units: units on a scale
    least squares mean (standard error)
        Change at Week 1
    -11.43 ( 0.94 )
    -5.58 ( 0.93 )
        Change at Week 2
    -13.70 ( 1.02 )
    -9.53 ( 1.01 )
        Change at Week 3
    -16.79 ( 1.04 )
    -11.17 ( 1.01 )
    Statistical analysis title
    		 Change at Week 1
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Placebo v Ziprasidone
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    -5.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.16
         upper limit
    		 -3.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.17
    Statistical analysis title
    		 Change at Week 2
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    -4.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.74
         upper limit
    		 -1.59
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.3
    Statistical analysis title
    		 Change at Week 3
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    -5.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.21
         upper limit
    		 -3.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.31

    Secondary: Clinical Global Impression of Improvement (CGI-I) Scores at Weeks 1, 2, 3, and 4

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    End point title
    		 Clinical Global Impression of Improvement (CGI-I) Scores at Weeks 1, 2, 3, and 4
    End point description
    CGI-I: 7-point clinician rated scale which rates the subject’s improvement or worsening from baseline, ranging from 1 (very much improved) to 7 (very much worse), higher scores indicate less improvement. ITT population included all randomised subjects who had baseline measurements, took at least 1 dose of study medication (ziprasidone or placebo) and with at least 1 post-baseline visit.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 3, 4
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    85
    83
    Units: units on a scale
    least squares mean (standard error)
        Week 1
    2.89 ( 0.11 )
    3.41 ( 0.11 )
        Week 2
    2.75 ( 0.12 )
    2.89 ( 0.12 )
        Week 3
    2.42 ( 0.12 )
    2.68 ( 0.12 )
        Week 4
    2.30 ( 0.13 )
    2.64 ( 0.13 )
    Statistical analysis title
    		 Change at Week 1
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.78
         upper limit
    		 -0.26
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13
    Statistical analysis title
    		 Change at Week 2
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.349
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 0.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Change at Week 3
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.103
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.57
         upper limit
    		 0.05
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    		 Change at Week 4
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.044
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.68
         upper limit
    		 -0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.17

    Other pre-specified: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence in a subject who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalisation; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs. The safety analysis set included all subjects who were randomised and took at least 1 dose of study medication (ziprasidone or placebo).
    End point type
    Other pre-specified
    End point timeframe
    Screening up to maximum of 35 days after administration of the final dose of study medication (maximum up to 11 weeks)
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    86
    85
    Units: subjects
        AEs
    67
    50
        SAEs
    3
    0
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Number of Subjects With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS)
    End point description
    C-SSRS: a measure used to identify and assess subjects at risk for suicide. It is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. C-SSRS items were mapped to the following C-CASA categories: completed suicide, attempted suicide (actual attempt; aborted attempt; interrupted attempt), non-suicidal self-injurious behavior (SIB), preparatory acts, suicidal ideation (wish to be dead; non-specific active suicidal thoughts [AST]; active suicidal ideation [ASI] with any methods [not plan], without intent to act; ASI with some intent to act, without specific plan; ASI with specific plan and intent; SIB, no suicidal intent). ITT population included all randomised subjects who had baseline measurements, took at least 1 dose of study medication (ziprasidone or placebo) and with at least 1 post-baseline visit. “n” = number of subjects evaluable for specified categories.
    End point type
    Other pre-specified
    End point timeframe
    Screening (maximum up to 14 days before Day 1), Baseline (Day 1), Week 1, 2, 3, 4, Early termination Visit (ET = anytime till Week 4), Follow up Visit (FW = anytime from last dose of study drug up to 35 days till Week 11)
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    85
    83
    Units: Subjects
        Screening (n =85, 83): Completed Suicide
    0
    0
        Screening (n =85, 83): Actual Attempt
    5
    3
        Screening (n =85, 83): Aborted Attempt
    0
    0
        Screening (n =85, 83): Interrupted Attempt
    0
    1
        Screening (n =85, 83): Non-Suicidal SIB
    10
    5
        Screening (n =85, 83): Preparatory Acts
    0
    1
        Screening (n =85, 83): Wish To Be Dead
    25
    25
        Screening (n =85, 83): Non-specific AST
    16
    13
        Screening (n =85, 83): ASI with no plan, intent
    0
    0
        Screening (n=85, 83): ASI with no plan,some intent
    0
    0
        Screening (n =85, 83): ASI with plan, intent
    0
    0
        Screening (n =85, 83): SIB, no intent
    0
    0
        Baseline (n =85, 83): Completed Suicide
    0
    0
        Baseline (n =85, 83): Actual Attempt
    0
    0
        Baseline (n =85, 83): Aborted Attempt
    0
    0
        Baseline (n =85, 83): Interrupted Attempt
    0
    0
        Baseline (n =85, 83): Non-Suicidal SIB
    0
    0
        Baseline (n =85, 83): Preparatory Acts
    0
    0
        Baseline (n =85, 83): Wish To Be Dead
    1
    0
        Baseline (n =85, 83): Non-specific AST
    0
    0
        Baseline (n=85, 83): ASI with no plan, intent
    4
    7
        Baseline (n=85,83): ASI with no plan,some intent
    2
    3
        Baseline (n =85, 83): ASI with plan, intent
    4
    3
        Baseline (n =85,83): SIB, no intent
    0
    0
        Week 1 (n =78, 83): Completed Suicide
    0
    0
        Week 1 (n =78, 83): Actual Attempt
    0
    0
        Week 1 (n =78, 83): Aborted Attempt
    0
    0
        Week 1 (n =78, 83): Interrupted Attempt
    0
    0
        Week 1 (n =78, 83): Non-Suicidal SIB
    0
    0
        Week 1 (n =78, 83): Preparatory Acts
    0
    0
        Week 1 (n =78, 83): Wish To Be Dead
    0
    1
        Week 1 (n =78, 83): Non-specific AST
    0
    0
        Week 1 (n =78, 83): ASI with no plan, intent
    0
    0
        Week 1 (n =78, 83): ASI with no plan, some intent
    0
    0
        Week 1 (n =78, 83): ASI with plan, intent
    0
    0
        Week 1(n =78, 83): SIB, no intent
    0
    0
        Week 2 (n =67, 78): Completed Suicide
    0
    0
        Week 2 (n =67, 78): Actual Attempt
    0
    0
        Week 2 (n =67, 78): Aborted Attempt
    0
    0
        Week 2 (n =67, 78): Interrupted Attempt
    0
    0
        Week 2 (n =67, 78): Non-Suicidal SIB
    0
    0
        Week 2 (n =67, 78): Preparatory Acts
    0
    0
        Week 2 (n =67, 78): Wish To Be Dead
    0
    0
        Week 2 (n =67, 78): Non-specific AST
    0
    0
        Week 2 (n =67, 78): ASI with no plan, intent
    0
    0
        Week 2 (n =67, 78): ASI with no plan, some intent
    0
    0
        Week 2 (n =67, 78): ASI with plan, intent
    0
    0
        Week 2(n =67, 78): SIB, no intent
    0
    0
        Week 3 (n =64, 75): Completed Suicide
    0
    0
        Week 3 (n =64, 75): Actual Attempt
    0
    0
        Week 3 (n =64, 75): Aborted Attempt
    0
    0
        Week 3 (n =64, 75): Interrupted Attempt
    0
    0
        Week 3 (n =64, 75): Non-Suicidal SIB
    0
    0
        Week 3 (n =64, 75): Preparatory Acts
    0
    0
        Week 3 (n =64, 75): Wish To Be Dead
    0
    0
        Week 3 (n =64, 75): Non-specific AST
    0
    0
        Week 3 (n =64, 75): ASI with no plan, intent
    0
    0
        Week 3 (n =64, 75): ASI with no plan, some intent
    0
    0
        Week 3 (n =64, 75): ASI with plan, intent
    0
    0
        Week 3 (n =64, 75): SIB, no intent
    0
    0
        Week 4 (n =63, 75): Completed Suicide
    0
    0
        Week 4 (n =63, 75): Actual Attempt
    0
    0
        Week 4 (n =63, 75): Aborted Attempt
    0
    0
        Week 4 (n =63, 75): Interrupted Attempt
    0
    0
        Week 4 (n =63, 75): Non-Suicidal SIB
    1
    0
        Week 4 (n =63, 75): Preparatory Acts
    0
    0
        Week 4 (n =63, 75): Wish To Be Dead
    2
    0
        Week 4 (n =63, 75): Non-specific AST
    1
    0
        Week 4 (n =63, 75): ASI with no plan, intent
    0
    0
        Week 4 (n =63, 75): ASI with no plan, some intent
    0
    0
        Week 4 (n =63, 75): ASI with plan, intent
    0
    0
        Week 4 (n =63, 75): SIB, no intent
    0
    0
        ET (n =21, 5): Completed Suicide
    0
    0
        ET (n =21, 5): Actual Attempt
    0
    0
        ET (n =21, 5): Aborted Attempt
    0
    0
        ET (n =21, 5): Interrupted Attempt
    0
    0
        ET (n =21, 5): Non-Suicidal SIB
    0
    0
        ET (n =21, 5): Preparatory Acts
    0
    0
        ET (n =21, 5): Wish To Be Dead
    1
    0
        ET (n =21, 5): Non-specific AST
    1
    0
        ET (n =21, 5): ASI with no plan, intent
    1
    0
        ET (n =21, 5): ASI with no plan, some intent
    0
    0
        ET (n =21, 5): ASI with plan, intent
    0
    0
        ET (n =21, 5): SIB, no intent
    0
    0
        FW (n =62, 64): Completed Suicide
    0
    0
        FW (n =62, 64): Actual Attempt
    1
    0
        FW (n =62, 64): Aborted Attempt
    0
    0
        FW (n =62, 64): Interrupted Attempt
    0
    0
        FW (n =62, 64): Non-Suicidal SIB
    0
    0
        FW (n =62, 64): Preparatory Acts
    0
    0
        FW (n =62, 64): Wish To Be Dead
    2
    0
        FW (n =62, 64): Non-specific AST
    0
    0
        FW (n =62, 64): ASI with no plan, intent
    0
    0
        FW (n =62, 64): ASI with no plan, some intent
    0
    0
        FW (n =62, 64): ASI with plan, intent
    0
    0
        FW (n =62, 64): SIB, no intent
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects who Took At least 1 Concomitant Medication and Concomitant Non-Drug Treatments/Procedures

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    End point title
    		 Number of Subjects who Took At least 1 Concomitant Medication and Concomitant Non-Drug Treatments/Procedures
    End point description
    Concomitant medications or treatments were those prescription and over-the-counter drugs and supplements or non drug treatment/procedures that a study subject had taken along with the study medication as per investigator's discretion. The safety analysis set included all subjects who were randomised and took at least 1 dose of study medication (ziprasidone or placebo).
    End point type
    Other pre-specified
    End point timeframe
    Screening up to Week 5
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    86
    85
    Units: subjects
        Concomitant Medication
    55
    47
        Concomitant Non-Drug Treatments/Procedures
    6
    7
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Laboratory Abnormalities

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    End point title
    		 Number of Subjects With Laboratory Abnormalities
    End point description
    Hematology-hemoglobin(Hg),hematocrit,erythrocytes(ery)<0.8*LLN,ery mean corpuscular volume <0.9*LLN>1.1*ULN,platelets<0.5*LLN>1.75*ULN,leukocytes(leu)<0.6*LLN>1.5*ULN,lymphocytes(lym),lym/leu,neutrophils(neu),neu/leu<0.8*LLN>1.2*ULN,basophils (bas),bas/leu,eosinophils(eos),eos/leu, monocytes(mon),mon/leu>1.2*ULN;Clinical chemistry bilirubin:total,direct,indirect>1.5*ULN, aspartate aminotransferase(AT),alanine AT,gamma glutamyl transferase,lactate dehydrogenase,alkaline phosphatase>3.0*ULN,protein,albumin<0.8*LLN>1.2*ULN,blood urea nitrogen,creatinine>1.3*ULN, urate>1.2*ULN,HDL<0.8*LLN;LDL>1.2*ULN cholesterol(CH),sodium<0.95*LLN>1.05*ULN,potassium, chloride,calcium,magnesium,bicarbonate<0.9*LLLN>1.1*ULN,phosphate,free thyroxine,thyroid stimulating hormone<0.8*LLN>1.2*ULN,prolactin>1.1*ULN,glucose<0.6*LLN>1.5*ULN,HgA1C,CH, triglycerides>1.3*ULN,creatine kinase>2.0*ULN;Urinalysis-specific gravity<1.003>1.030,pH<4.5 >8,urine glucose,protein,Hg,ketones:>=1.Safety set.N=subjects evaluable.
    End point type
    Other pre-specified
    End point timeframe
    Screening up to Week 5
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    84
    83
    Units: Subjects
    50
    62
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Physical Examination Abnormalities

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    End point title
    		 Number of Subjects With Physical Examination Abnormalities
    End point description
    Parameters assessed for physical examination included: oral/tympanic temperature, general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts (if medically indicated), abdomen, external genitalia [if medically indicated], extremities, back/spinal system, lymph nodes or worsening of medical history conditions. Abnormality in physical examination was at the investigator's discretion. The safety analysis set included all subjects who were randomised and took at least 1 dose of study medication (ziprasidone or placebo).
    End point type
    Other pre-specified
    End point timeframe
    Screening up to Week 4
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    86
    85
    Units: Subjects
    4
    5
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Blood Pressure at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit

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    End point title
    		 Change From Baseline in Blood Pressure at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit
    End point description
    Change from baseline in sitting and standing systolic blood pressure (SBP) and diastolic blood pressure (DBP) in millimeter of mercury (mmHg) was reported. The safety analysis set included all subjects who were randomised and took at least 1 dose of study medication (ziprasidone or placebo). Here ‘n’ signifies number of subjects evaluable for each specified category.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 1, 2, 3, 4, Early termination Visit (ET = anytime till Week 4), Follow up Visit (FW = anytime from last dose of study drug up to 35 days till Week 11)
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    86
    85
    Units: millimeter of mercury
    arithmetic mean (standard deviation)
        Sitting SBP, Baseline (n = 86, 85)
    110.5 ( 9.84 )
    110.9 ( 11.45 )
        Sitting SBP, Change at Week 1 (n = 78, 83)
    0.7 ( 6.90 )
    0.2 ( 8.71 )
        Sitting SBP, Change at Week 2 (n = 67, 78)
    0.2 ( 9.65 )
    0.1 ( 9.26 )
        Sitting SBP, Change at Week 3 (n = 64, 75)
    -0.7 ( 10.12 )
    -0.6 ( 8.93 )
        Sitting SBP, Change at Week 4 (n = 63, 75)
    -0.7 ( 10.60 )
    -2.2 ( 10.39 )
        Sitting SBP, Change at ET (n = 20, 5)
    0.7 ( 7.87 )
    6.4 ( 5.90 )
        Sitting SBP, Change at FW (n = 21, 22)
    -1.4 ( 12.44 )
    -2.2 ( 8.35 )
        Standing SBP, Baseline (n = 86, 85)
    110.7 ( 9.53 )
    112.0 ( 10.16 )
        Standing SBP, Change at Week 1 (n = 78, 83)
    0.8 ( 7.67 )
    -2.5 ( 10.38 )
        Standing SBP, Change at Week 2 (n = 67, 78)
    0.1 ( 9.13 )
    -1.8 ( 9.71 )
        Standing SBP, Change at Week 3 (n = 64, 75)
    -0.1 ( 9.68 )
    -1.8 ( 9.71 )
        Standing SBP, Change at Week 4 (n = 63, 75)
    -0.8 ( 9.50 )
    -2.5 ( 10.77 )
        Standing SBP, Change at ET (n = 20, 5)
    -2.1 ( 10.14 )
    5.6 ( 13.58 )
        Standing SBP, Change at FW (n = 21, 22)
    -4.9 ( 11.86 )
    -4.4 ( 10.01 )
        Sitting DBP, Baseline (n = 86, 85)
    68.8 ( 7.99 )
    70.3 ( 7.94 )
        Sitting DBP, Change at Week 1 (n = 78, 83)
    0.7 ( 7.72 )
    -1.5 ( 8.49 )
        Sitting DBP, Change at Week 2 (n = 67, 78)
    1.0 ( 9.76 )
    -0.6 ( 9.40 )
        Sitting DBP, Change at Week 3 (n = 64, 75)
    0.2 ( 9.36 )
    0.1 ( 8.03 )
        Sitting DBP, Change at Week 4 (n = 63, 75)
    1.1 ( 8.18 )
    -0.6 ( 10.22 )
        Sitting DBP, Change at ET (n = 20, 5)
    -1.8 ( 9.65 )
    2.0 ( 8.46 )
        Sitting DBP, Change at FW (n = 21, 22)
    2.7 ( 8.64 )
    1.7 ( 6.75 )
        Standing DBP, Baseline (n = 86, 85)
    70.3 ( 6.98 )
    72.3 ( 7.91 )
        Standing DBP, Change at Week 1 (n = 78, 83)
    1.5 ( 7.40 )
    -1.6 ( 8.46 )
        Standing DBP, Change at Week 2 (n = 67, 78)
    -0.1 ( 7.83 )
    -1.7 ( 8.75 )
        Standing DBP, Change at Week 3 (n = 64, 75)
    -1.1 ( 7.91 )
    -1.6 ( 10.27 )
        Standing DBP, Change at Week 4 (n = 63, 75)
    1.0 ( 7.76 )
    -0.5 ( 9.83 )
        Standing DBP, Change at ET (n = 20, 5)
    1.3 ( 10.22 )
    1.6 ( 7.60 )
        Standing DBP, Change at FW (n = 21, 22)
    1.2 ( 8.41 )
    -2.1 ( 12.89 )
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit

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    End point title
    		 Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit
    End point description
    Change from baseline in pulse rate in (beats per minute) was reported in sitting and standing positions. The safety analysis set included all subjects who were randomised and took at least 1 dose of study medication (ziprasidone or placebo). Here ‘n’ signifies number of subjects evaluable for each specified category.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 1, 2, 3, 4, Early termination Visit (ET = anytime till Week 4), Follow up Visit (FW = anytime from last dose of study drug up to 35 days till Week 11)
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    86
    85
    Units: beats per minute
    arithmetic mean (standard deviation)
        Sitting, Baseline (n = 86, 85)
    79.1 ( 12.58 )
    75.8 ( 9.80 )
        Sitting, Change at Week 1 (n = 78, 83)
    -0.9 ( 11.24 )
    -2.0 ( 9.40 )
        Sitting, Change at Week 2 (n = 67, 78)
    -2.4 ( 11.75 )
    1.5 ( 8.82 )
        Sitting, Change at Week 3 (n = 64, 75)
    -0.5 ( 12.79 )
    2.3 ( 10.61 )
        Sitting, Change at Week 4 (n = 63, 75)
    -2.3 ( 11.49 )
    -0.2 ( 10.30 )
        ET: Sitting (n = 20, 5)
    3.5 ( 14.02 )
    1.6 ( 7.02 )
        FW: Sitting (n = 21, 22)
    2.0 ( 11.32 )
    3.1 ( 11.73 )
        Standing, Baseline (n = 86, 85)
    84.6 ( 12.23 )
    83.3 ( 10.95 )
        Standing, Change at Week 1 (n = 78, 83)
    2.1 ( 10.77 )
    -2.2 ( 10.18 )
        Standing, Change at Week 2 (n = 67, 78)
    -0.4 ( 12.25 )
    1.9 ( 10.19 )
        Standing, Change at Week 3 (n = 64, 75)
    1.4 ( 13.54 )
    2.6 ( 11.70 )
        Standing, Change at Week 4 (n = 63, 75)
    -0.7 ( 11.77 )
    -0.6 ( 12.83 )
        ET: Standing (n = 20, 5)
    7.9 ( 13.98 )
    -6.2 ( 21.12 )
        FW: Standing (n = 21, 22)
    5.4 ( 10.15 )
    4.5 ( 11.67 )
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Height and Waist Circumference at Week 4 and Early Termination Visit

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    End point title
    		 Change From Baseline in Height and Waist Circumference at Week 4 and Early Termination Visit
    End point description
    Change from baseline in height and waist circumference in centimeter (cm) was reported. The safety analysis set included all subjects who were randomised and took at least 1 dose of study medication (ziprasidone or placebo). Here ‘n’ signifies number of subjects evaluable for each specified category.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 4, Early termination Visit (ET = anytime till Week 4)
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    86
    85
    Units: centimeter
    arithmetic mean (standard deviation)
        Height, Baseline (n = 86, 85)
    157.9 ( 10.63 )
    159.7 ( 11.41 )
        Height, Change at Week 4 (n = 63, 75)
    0.4 ( 0.60 )
    0.7 ( 1.77 )
        Height, Change at ET (n = 19, 5)
    0.2 ( 0.54 )
    0.5 ( 0.73 )
        Waist circumference, Baseline (n = 86, 85)
    76.9 ( 12.22 )
    74.9 ( 10.56 )
        Waist circumference, Change at Week 4 (n = 63, 75)
    -0.1 ( 2.79 )
    0.3 ( 3.26 )
        Waist circumference, Change at ET (n = 19, 5)
    0.4 ( 3.77 )
    1.0 ( 1.74 )
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Body Weight at Week 4 and Early Termination Visit

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    End point title
    		 Change From Baseline in Body Weight at Week 4 and Early Termination Visit
    End point description
    Change from baseline in weight in kilogram (kg) was reported. The safety analysis set included all subjects who were randomised and took at least 1 dose of study medication (ziprasidone or placebo). Here ‘n’ signifies number of subjects evaluable for each specified category.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 4, Early termination Visit (ET = anytime till Week 4)
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    86
    85
    Units: kilogram
    arithmetic mean (standard deviation)
        Baseline (n = 86, 85)
    57.5 ( 14.52 )
    58.0 ( 14.54 )
        Change at Week 4 (n = 63, 75)
    0.3 ( 1.97 )
    0.8 ( 2.04 )
        Change at ET (n = 19, 5)
    -0.3 ( 1.75 )
    1.0 ( 1.46 )
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Body Mass Index (BMI) at Week 4 and Early Termination Visit

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    End point title
    		 Change From Baseline in Body Mass Index (BMI) at Week 4 and Early Termination Visit
    End point description
    Change from baseline in BMI in kilogram per meter square (kg/m^2) was reported. The safety analysis set included all subjects who were randomised and took at least 1 dose of study medication (ziprasidone or placebo). Here ‘n’ signifies number of subjects evaluable for each specified category.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 4, Early termination Visit (ET = anytime till Week 4)
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    86
    85
    Units: kilogram per meter square
    arithmetic mean (standard deviation)
        Baseline (n = 86, 85)
    22.8 ( 4.15 )
    22.5 ( 3.76 )
        Change at Week 4 (n = 63, 75)
    0.1 ( 0.79 )
    0.2 ( 0.92 )
        Change at ET (n = 19, 5)
    -0.3 ( 0.95 )
    0.3 ( 0.51 )
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Body Mass Index (BMI) Z-score at Week 4 and Early Termination Visit

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    End point title
    		 Change From Baseline in Body Mass Index (BMI) Z-score at Week 4 and Early Termination Visit
    End point description
    BMI z-score was reported using the Children’s Hospital of Philadelphia z-score calculator. Z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher BMI. The safety analysis set included all subjects who were randomised and took at least 1 dose of study medication (ziprasidone or placebo). Here ‘n’ signifies number of subjects evaluable for each specified category.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 4, Early termination Visit (ET = anytime till Week 4)
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    86
    85
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n = 86, 85)
    0.8 ( 0.87 )
    0.7 ( 0.82 )
        Change at Week 4 (n = 63, 75)
    0.0 ( 0.18 )
    -0.0 ( 0.24 )
        Change at ET (n = 19, 5)
    -0.0 ( 0.15 )
    -0.0 ( 0.22 )
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Pre-defined Categories of Electrocardiogram (ECG) Findings

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    End point title
    		 Number of Subjects With Pre-defined Categories of Electrocardiogram (ECG) Findings
    End point description
    Pre-defined categories for ECG were: heart rate intervals - QT interval corrected using the Fridericia's formula (QTCF) value greater than or equal to (>=450) millisecond (msec), >=460 msec, >=480 msec, >=500 msec, >=30 msec increase, >=60 msec increase, >=75 msec increase, QT interval corrected using the Bazett’s correction (QTCB) value >=450 msec, >=460 msec, >=480 msec, >=500 msec, >=30 msec increase, >=60 msec increase, >=75 msec increase, PR value >=25 percentage increase, QRS value >=25 percentage increase, QT value >=25 percentage increase, RR value >=25 percentage increase, and HR value >=25 percentage increase. The safety analysis set included all subjects who were randomised and took at least 1 dose of study medication (ziprasidone or placebo). Here 'number of subjects analysed’ signifies number of subjects who were evaluable for this endpoint.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 1, 2, 3, 4, Early termination Visit (anytime till Week 4), Follow up Visit (anytime from last dose of study drug up to 35 days till Week 11)
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    85
    83
    Units: Subjects
        QTcF at >=450 msec
    3
    1
        QTcF at >=460 msec
    1
    0
        QTcF at >=480 msec
    0
    0
        QTcF at >=500 msec
    0
    0
        QTcF at >=30 msec increase
    9
    4
        QTcF at >=60 msec increase
    0
    0
        QTcF at >=75 msec increase
    0
    0
        QTcB at >=450 msec
    14
    7
        QTcB at >=460 msec
    8
    3
        QTcB at >=480 msec
    1
    0
        QTcB at >=500 msec
    0
    0
        QTcB at >=30 msec increase
    16
    7
        QTcB at >=60 msec increase
    0
    0
        QTcB at >=75 msec increase
    0
    0
        PR at >=25% increase
    0
    0
        QRS at >=25% increase
    3
    1
        QT at >=25% increase
    0
    0
        RR at >=25% increase
    12
    14
        HR at >=25% increase
    18
    9
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Weeks 1, 2, 3, and 4 and Early Termination Visit

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    End point title
    		 Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Weeks 1, 2, 3, and 4 and Early Termination Visit
    End point description
    CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (maximum impairment). Higher scores indicated greater impairment. Total score calculated as sum of the 17 items ranged from 1 (no impairment) to 119 (maximum impairment); higher score indicated greater impairment. ITT population included all randomised subjects who had baseline measurements, took at least 1 dose of study medication (ziprasidone or placebo) and with at least 1 post-baseline visit. Here 'number of subjects analysed’ signifies number of subjects who were evaluable for this endpoint and ‘n’ signifies number of subjects evaluable for each specified category.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 1, 2, 3, 4, Early termination Visit (ET = anytime till Week 4)
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    85
    83
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n = 85, 83)
    29.0 ( 6.62 )
    28.3 ( 5.74 )
        Change at Week 1 (n = 78, 83)
    -2.5 ( 5.78 )
    -0.8 ( 4.85 )
        Change at Week 2 (n = 67, 78)
    -2.9 ( 6.31 )
    -2.4 ( 5.37 )
        Change at Week 3 (n = 64, 75)
    -3.7 ( 6.39 )
    -3.3 ( 6.15 )
        Change at Week 4 (n = 63, 75)
    -3.6 ( 6.53 )
    -3.8 ( 5.99 )
        Change at ET (n = 20, 5)
    2.3 ( 10.46 )
    -1.2 ( 4.60 )
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Weeks 1, 2, 3, and 4

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    End point title
    		 Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Weeks 1, 2, 3, and 4
    End point description
    SARS: 10-item clinician rated instrument to assess parkinsonian symptoms and related extrapyramidal side effects. All 10 items were anchored on a 5-point scale: range 0 (absence of condition, normal) to 4 (the most extreme form of condition). Total score is sum of individual item scores, ranged from 0 (normal) to 40 (most extreme symptoms and effects); higher score indicates more affected. ITT population included all randomised subjects who had baseline measurements, took at least 1 dose of study medication (ziprasidone or placebo) and with at least 1 post-baseline visit.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 1, 2, 3, 4
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    85
    83
    Units: units on a scale
    least squares mean (standard error)
        Change at Week 1
    0.09 ( 0.04 )
    -0.01 ( 0.04 )
        Change at Week 2
    0.11 ( 0.05 )
    -0.00 ( 0.05 )
        Change at Week 3
    0.11 ( 0.05 )
    -0.00 ( 0.05 )
        Change at Week 4
    0.09 ( 0.04 )
    -0.00 ( 0.04 )
    Statistical analysis title
    		 Change at Week 1
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05
    Statistical analysis title
    		 Change at Week 2
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.124
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.07
    Statistical analysis title
    		 Change at Week 3
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.084
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.06
    Statistical analysis title
    		 Change at Week 4
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.104
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05

    Other pre-specified: Change From Baseline in Barnes Akathisia Rating Scale (BAS): Global Clinical Assessment of Akathisia Subscale Score at Weeks 1, 2, 3, and 4

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    End point title
    		 Change From Baseline in Barnes Akathisia Rating Scale (BAS): Global Clinical Assessment of Akathisia Subscale Score at Weeks 1, 2, 3, and 4
    End point description
    BAS: clinician rated scale to assess akathisia by determining the degree of subjective restlessness and distress associated with restlessness. First 3 items (objective, subjective, and distress related to restlessness) were rated on a 4-point scale with range 0 (no symptoms) to 3 (maximum severity of symptoms). Item 4, global clinical assessment of akathisia, was rated on a 6-point scale range 0 (no symptoms) to 5 (maximum severity of symptoms); higher score indicates increased severity. ITT population included all randomised subjects who had baseline measurements, took at least 1 dose of study medication (ziprasidone or placebo) and with at least 1 post-baseline visit.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 1, 2, 3, 4
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    85
    83
    Units: units on a scale
    least squares mean (standard error)
        Change at Week 1
    -0.01 ( 0.01 )
    0.02 ( 0.01 )
        Change at Week 2
    0.04 ( 0.03 )
    0.04 ( 0.03 )
        Change at Week 3
    0.01 ( 0.02 )
    0.01 ( 0.01 )
        Change at Week 4
    0.01 ( 0.01 )
    -0.01 ( 0.01 )
    Statistical analysis title
    		 Change at Week 1
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.169
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02
    Statistical analysis title
    		 Change at Week 2
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.893
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05
    Statistical analysis title
    		 Change at Week 3
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.915
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02
    Statistical analysis title
    		 Change at Week 4
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.289
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.01

    Other pre-specified: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) - Movement Cluster Score at Weeks 1, 2, 3, and 4

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    End point title
    		 Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) - Movement Cluster Score at Weeks 1, 2, 3, and 4
    End point description
    AIMS: clinician rated 12-item scale to document occurrences of dyskinesia in subjects, specifically tardive dyskinesia. Items 1 to 10, scored as 0 (none) to 4 (severe); higher score indicates greater severity. Items 11 to 14 are questions with No or Yes response. Only the sum of the first 7 items were calculated to evaluate AIMS movement cluster score with a core range of 0 (none) to 28 (extreme severity); higher score indicates greater severity. ITT population included all randomised subjects who had baseline measurements, took at least 1 dose of study medication (ziprasidone or placebo) and with at least 1 post-baseline visit.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 1, 2, 3, 4
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    85
    83
    Units: units on a scale
    least squares mean (standard error)
        Change at Week 1
    0.03 ( 0.01 )
    0.00 ( 0.01 )
        Change at Week 2
    0.03 ( 0.01 )
    0.00 ( 0.01 )
        Change at Week 3
    0.08 ( 0.03 )
    0.00 ( 0.03 )
        Change at Week 4
    0.05 ( 0.02 )
    0.00 ( 0.02 )
    Statistical analysis title
    		 Change at Week 1
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.145
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02
    Statistical analysis title
    		 Change at Week 2
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.148
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02
    Statistical analysis title
    		 Change at Week 3
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.082
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.04
    Statistical analysis title
    		 Change at Week 4
    Statistical analysis description
    Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with subject as a random effect.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.07
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening up to maximum of 35 days after administration of the final dose of study medication (maximum up to 11 weeks)
    Adverse event reporting additional description
    Same event may appear as both AE and SAE. An event may be categorized as serious in 1 subject and non-serious in other, or subject may experience both SAE and non-SAE.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Ziprasidone
    Reporting group description
    		 Subjects were randomised to receive ziprasidone capsules orally once daily for 4 weeks. Dose was titrated over the first 7-14 days of treatment, and the stable dose was maintained for remaining treatment period. Subjects with body weight less than 45 kg received 60 to 80 mg/day and subjects with body weight >=45 kg received 120-160 mg/day, as per investigator discretion. Subjects after completion or discontinuation of treatment were eligible to enroll in open label extension study A1281201 or were followed-up to 35 days (5 weeks) after last dose in this study.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomised to receive placebo capsules matched to ziprasidone once daily for 4 weeks. Subjects after completion or discontinuation of treatment were eligible to enroll in open label extension study A1281201 or were followed-up to 35 days (5 weeks) after last dose in this study.

    Serious adverse events
    		 Ziprasidone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 86 (3.49%)
    0 / 85 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Sunburn
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Ziprasidone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 86 (75.58%)
    35 / 85 (41.18%)
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    5 / 86 (5.81%)
    0 / 85 (0.00%)
         occurrences all number
    5
    0
    Dizziness
         subjects affected / exposed
    6 / 86 (6.98%)
    2 / 85 (2.35%)
         occurrences all number
    7
    2
    Headache
         subjects affected / exposed
    9 / 86 (10.47%)
    8 / 85 (9.41%)
         occurrences all number
    10
    9
    Hypersomnia
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Sedation
         subjects affected / exposed
    8 / 86 (9.30%)
    3 / 85 (3.53%)
         occurrences all number
    11
    3
    Somnolence
         subjects affected / exposed
    27 / 86 (31.40%)
    7 / 85 (8.24%)
         occurrences all number
    39
    7
    Speech disorder
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Tremor
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    19 / 86 (22.09%)
    2 / 85 (2.35%)
         occurrences all number
    23
    4
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    3 / 86 (3.49%)
    1 / 85 (1.18%)
         occurrences all number
    4
    2
    Diarrhoea
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 85 (1.18%)
         occurrences all number
    2
    1
    Nausea
         subjects affected / exposed
    12 / 86 (13.95%)
    5 / 85 (5.88%)
         occurrences all number
    14
    6
    Salivary hypersecretion
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Vomiting
         subjects affected / exposed
    9 / 86 (10.47%)
    3 / 85 (3.53%)
         occurrences all number
    12
    6
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 85 (1.18%)
         occurrences all number
    2
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 86 (0.00%)
    4 / 85 (4.71%)
         occurrences all number
    0
    4
    Anxiety
         subjects affected / exposed
    3 / 86 (3.49%)
    0 / 85 (0.00%)
         occurrences all number
    3
    0
    Initial insomnia
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Insomnia
         subjects affected / exposed
    3 / 86 (3.49%)
    1 / 85 (1.18%)
         occurrences all number
    4
    1
    Irritability
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Joint stiffness
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Myalgia
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 86 (2.33%)
    3 / 85 (3.53%)
         occurrences all number
    2
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    10 / 86 (11.63%)
    0 / 85 (0.00%)
         occurrences all number
    10
    0
    Increased appetite
         subjects affected / exposed
    3 / 86 (3.49%)
    1 / 85 (1.18%)
         occurrences all number
    3
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Aug 2018
    Pregnancy testing was done weekly with no 14 day screening window.
    19 Feb 2019
    Language was applied to reflect the FDA agreed upon increase in sample size due to the rater training issue and adding a separate sensitivity analysis of final data set.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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