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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Low-dose Lurasidone in Acutely Psychotic Subjects with Schizophrenia

    Summary
    EudraCT number
    		 2012-005271-14
    Trial protocol
    		 SK   RO  
    Global end of trial date
    18 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Sep 2016
    First version publication date
    18 Sep 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D1050303
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01821378
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sunovion Pharmaceuticals Inc.
    Sponsor organisation address
    One Bridge Plaza North, Suite 510, Fort Lee, United States, 07024
    Public contact
    Medical Director, Sunovion Pharmaceuticals Inc., 001 8665036351, clinicaltrialdisclosure@sunovion.com
    Scientific contact
    Medical Director, Sunovion Pharmaceuticals Inc., 001 8665036351, clinicaltrialdisclosure@sunovion.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia.
    Protection of trial subjects
    The trial was conducted in accordance with the ethical principles of Good Clinical Practice, according to the ICH Harmonized Tripartite Guideline.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 May 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Colombia: 19
    Country: Number of subjects enrolled
    Russian Federation: 99
    Country: Number of subjects enrolled
    Romania: 78
    Country: Number of subjects enrolled
    United States: 128
    Country: Number of subjects enrolled
    Ukraine: 60
    Country: Number of subjects enrolled
    Slovakia: 27
    Worldwide total number of subjects
    411
    EEA total number of subjects
    105
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    407
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of lurasidone 20 mg/day administered one daily over a 6-week period in acutely psychotic subjects with chronic schizophrenia. Enrollment started on 16May2013.

    Pre-assignment
    Screening details
    		 Screen phase (up to 14 days) followed by a double-blind phase (6 weeks) and a follow-up visit (7 days post-last dose of study drug). Following the screening phase, subjects who continued to meet entry criteria were randomly assigned to 1 of 3 treatment groups: a fixed dose of lurasidone 20mg/day. lurasidone 80mg/day or Placebo in a 1:2:1 ratio.

    Pre-assignment period milestones
    Number of subjects started
    		 411
    Number of subjects completed
    		 411

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lurasidone 20 mg
    Arm description
    		 Lurasidone 20 mg once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    lurasidone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    lurasidone 20mg/once daily

    Arm title
    		 Lurasidone 80 mg - 160 mg
    Arm description
    		 The subjects who were randomized to lurasidone 80 mg/day at baseline (received lurasidone 80 mg/day or 160 mg/day throughout the study
    Arm type
    		 Experimental

    Investigational medicinal product name
    lurasidone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    lurasidone 80mg/once daily and also lurasidone 160 mg/once daily after week 2 for ENR 160 subjects (who received lurasidone 80 mg/day till Week 2, are classified to ENR at Week 2, and received lurasidone 160 mg/day after rerandomization at Week 2.

    Arm title
    		 Placebo
    Arm description
    		 Placebo Comparator once daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo/once daily

    Number of subjects in period 1
    		Lurasidone 20 mg Lurasidone 80 mg - 160 mg Placebo
    Started
    101
    198
    112
    Completed
    74
    145
    70
    Not completed
    27
    53
    42
         Consent withdrawn by subject
    15
    24
    12
         Adverse event, non-fatal
    2
    8
    8
         lost to follow up
    2
    4
    -
         lack of efficacy
    8
    15
    18
         Lost to follow-up
    -
    -
    1
         administrative
    -
    1
    2
         Protocol deviation
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lurasidone 20 mg
    Reporting group description
    		 Lurasidone 20 mg once daily

    Reporting group title
    Lurasidone 80 mg - 160 mg
    Reporting group description
    		 The subjects who were randomized to lurasidone 80 mg/day at baseline (received lurasidone 80 mg/day or 160 mg/day throughout the study

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo Comparator once daily

    Reporting group values
    		 Lurasidone 20 mg Lurasidone 80 mg - 160 mg Placebo Total
    Number of subjects
    		 101 198 112 411
    Age Categorical
    Please note: the demographic information is based on safety population (excluded one subject who was randomized but did not take any study medication).
    Units: participants
        <=18 years
    		 0 0 0 0
        Between 18 and 65 years
    		 99 196 112 407
        >=65 years
    		 2 2 0 4
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.5 ± 10.96 40.5 ± 11.44 40.7 ± 11.58 -
    Gender, Male/Female
    Units: participants
        Female
    		 36 79 34 149
        Male
    		 65 119 78 262
    Region of Enrollment
    Units: Subjects
        Colombia
    		 3 9 7 19
        Russian Federation
    		 23 49 27 99
        Romania
    		 22 38 18 78
        United States
    		 31 59 38 128
        Ukraine
    		 16 31 13 60
        Slovakia
    		 6 12 9 27
    Subject analysis sets

    Subject analysis set title
    ENR Lurasidone 80 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who are non-responders on Lurasidone 80 mg/day and rerandomized to Lurasidone 80 mg/day at week 2.

    Subject analysis set title
    ENR Lurasidone 160 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who are non-responders on Lurasidone 80 mg/day and rerandomized to Lurasidone 160 mg/day at week 2.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Randomized to Placebo group at baseline

    Subject analysis sets values
    		 ENR Lurasidone 80 mg ENR Lurasidone 160 mg Placebo
    Number of subjects
    52
    43
    112
    Age Categorical
    Please note: the demographic information is based on safety population (excluded one subject who was randomized but did not take any study medication).
    Units: participants
        <=18 years
    0
    0
        Between 18 and 65 years
    53
    43
        >=65 years
    2
    0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    42.2 ± 11
    41.3 ± 9.06
    ±
    Gender, Male/Female
    Units: participants
        Female
    23
    27
        Male
    32
    16
    Region of Enrollment
    Units: Subjects
        Colombia
    3
    3
        Russian Federation
    18
    13
        Romania
    9
    7
        United States
    16
    10
        Ukraine
    4
    8
        Slovakia
    5
    2

    End points

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    End points reporting groups
    Reporting group title
    Lurasidone 20 mg
    Reporting group description
    		 Lurasidone 20 mg once daily

    Reporting group title
    Lurasidone 80 mg - 160 mg
    Reporting group description
    		 The subjects who were randomized to lurasidone 80 mg/day at baseline (received lurasidone 80 mg/day or 160 mg/day throughout the study

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo Comparator once daily

    Subject analysis set title
    ENR Lurasidone 80 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who are non-responders on Lurasidone 80 mg/day and rerandomized to Lurasidone 80 mg/day at week 2.

    Subject analysis set title
    ENR Lurasidone 160 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who are non-responders on Lurasidone 80 mg/day and rerandomized to Lurasidone 160 mg/day at week 2.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Randomized to Placebo group at baseline

    Primary: Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 6 for lurasidone 20 mg and 80-160 mg versus placebo.

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    End point title
    		 Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 6 for lurasidone 20 mg and 80-160 mg versus placebo.
    End point description
    The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
    End point type
    Primary
    End point timeframe
    Baseline to 6 Weeks
    End point values
    		 Lurasidone 20 mg Lurasidone 80 mg - 160 mg Placebo
    Number of subjects analysed
    101
    198
    112
    Units: units on a scale
        least squares mean (standard error)
    -17.6 ± 1.93
    -24.9 ± 1.4
    -14.5 ± 1.89
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Lurasidone 20 mg v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.255
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.4
         upper limit
    		 2.2
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Placebo v Lurasidone 80 mg - 160 mg
    Number of subjects included in analysis
    310
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -10.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.9
         upper limit
    		 -5.7

    Secondary: Change in Clinical Global Impression-Severity of Illness (CGI-S) score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.

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    End point title
    		 Change in Clinical Global Impression-Severity of Illness (CGI-S) score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.
    End point description
    The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale (0-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.
    End point type
    Secondary
    End point timeframe
    Baseline to 6 Weeks
    End point values
    		 Lurasidone 20 mg Lurasidone 80 mg - 160 mg Placebo
    Number of subjects analysed
    101
    198
    112
    Units: units on a scale
        least squares mean (standard error)
    -0.93 ± 0.105
    -1.3 ± 0.076
    -0.73 ± 0.103
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Lurasidone 20 mg v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.169
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 0.09
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Placebo v Lurasidone 80 mg - 160 mg
    Number of subjects included in analysis
    310
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.83
         upper limit
    		 -0.32

    Secondary: Change from baseline to Week 6 for the lurasidone 20 mg, and lurasidone 80 - 160 mg groups versus the placebo group in the Montgomery-Asberg Depression Rating Scale total score

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    End point title
    		 Change from baseline to Week 6 for the lurasidone 20 mg, and lurasidone 80 - 160 mg groups versus the placebo group in the Montgomery-Asberg Depression Rating Scale total score
    End point description
    The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
    End point type
    Secondary
    End point timeframe
    Baseline to 6 Weeks
    End point values
    		 Lurasidone 20 mg Lurasidone 80 mg - 160 mg Placebo
    Number of subjects analysed
    93
    178
    108
    Units: units on a scale
        least squares mean (standard error)
    -2 ± 0.57
    -3.7 ± 0.41
    -1.7 ± 0.53
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Placebo v Lurasidone 20 mg
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.706
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 1.2
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Placebo v Lurasidone 80 mg - 160 mg
    Number of subjects included in analysis
    286
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 -0.7

    Secondary: Proportion of subjects who achieve a response, defined as 20% or greater improvement from baseline in Positive and Negative Syndrome Score (PANSS) total score at Week 6

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    End point title
    		 Proportion of subjects who achieve a response, defined as 20% or greater improvement from baseline in Positive and Negative Syndrome Score (PANSS) total score at Week 6
    End point description
    The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
    End point type
    Secondary
    End point timeframe
    6 Weeks
    End point values
    		 Lurasidone 20 mg Lurasidone 80 mg - 160 mg Placebo
    Number of subjects analysed
    101
    198
    112
    Units: percentage of participants
        number (not applicable)
    53
    72
    44
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Lurasidone 20 mg v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.173
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 2.5
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Placebo v Lurasidone 80 mg - 160 mg
    Number of subjects included in analysis
    310
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 5.2

    Secondary: Change from Week 2 to Week 6 for the ENR (early non-responders) lurasidone 160mg group vs the ENR (early non-responders) lurasidone 80 mg group in the following: PANSS total score

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    End point title
    		 Change from Week 2 to Week 6 for the ENR (early non-responders) lurasidone 160mg group vs the ENR (early non-responders) lurasidone 80 mg group in the following: PANSS total score
    End point description
    The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
    End point type
    Secondary
    End point timeframe
    week 2 to week 6
    End point values
    		 ENR Lurasidone 80 mg ENR Lurasidone 160 mg
    Number of subjects analysed
    52
    43
    Units: units on a scale
        least squares mean (standard error)
    -8.9 ± 2.2
    -16.6 ± 2.47
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    ENR Lurasidone 80 mg v ENR Lurasidone 160 mg
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.023
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.3
         upper limit
    		 -1.1

    Secondary: Change from baseline to Week 6 for the ENR lurasidone 80mg and ENR lurasidone 160mg groups vs the placebo in the MADRS total score

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    End point title
    		 Change from baseline to Week 6 for the ENR lurasidone 80mg and ENR lurasidone 160mg groups vs the placebo in the MADRS total score
    End point description
    The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
    End point type
    Secondary
    End point timeframe
    baseline to week 6
    End point values
    		 ENR Lurasidone 80 mg ENR Lurasidone 160 mg Placebo
    Number of subjects analysed
    52
    42
    108
    Units: units on a scale
        least squares mean (standard error)
    -2.5 ± 0.89
    -3.5 ± 0.1
    -1.7 ± 0.59
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    ENR Lurasidone 80 mg v Placebo
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.464
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 1.3
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Placebo v ENR Lurasidone 160 mg
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.122
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 0.5

    Secondary: Change from week 2 to week 6 for ENR Lurasidone 80 mg vs. ENR lurasidone 160 mg in CGI-S score

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    End point title
    		 Change from week 2 to week 6 for ENR Lurasidone 80 mg vs. ENR lurasidone 160 mg in CGI-S score
    End point description
    The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale (0-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.
    End point type
    Secondary
    End point timeframe
    week 2 to week 6
    End point values
    		 ENR Lurasidone 80 mg ENR Lurasidone 160 mg
    Number of subjects analysed
    52
    43
    Units: units on a scale
        least squares mean (standard error)
    -0.61 ± 0.116
    -0.96 ± 0.134
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    ENR Lurasidone 80 mg v ENR Lurasidone 160 mg
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.052
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0

    Secondary: Change from Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the PANSS total Score

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    End point title
    		 Change from Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the PANSS total Score
    End point description
    The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
    End point type
    Secondary
    End point timeframe
    Baseline to week 6
    End point values
    		 ENR Lurasidone 80 mg ENR Lurasidone 160 mg Placebo
    Number of subjects analysed
    52
    43
    112
    Units: units on a scale
        least squares mean (standard error)
    -14.4 ± 2.69
    -21.7 ± 3
    -14.4 ± 1.98
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    ENR Lurasidone 80 mg v Placebo
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.992
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.6
         upper limit
    		 6.6
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    ENR Lurasidone 160 mg v Placebo
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.044
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -7.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.4
         upper limit
    		 -0.2

    Secondary: Change from Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the CGI-S Score

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    End point title
    		 Change from Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the CGI-S Score
    End point description
    The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale, where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes. Reason for the discrepancy of the LS mean (SE) for placebo in outcome 2 and outcome 9 is because the different MMRM model used in outcome 2 and outcome 9. The treatment groups included in the MMRM model for outcome 2 are placebo, lurasidone 20 mg, and lurasidone 80-160 mg. The treatment groups included in the MMRM model for outcome 9 are placebo, ENR lurasidone 80 mg, and ENR lurasidone 160 mg.
    End point type
    Secondary
    End point timeframe
    baseline to week 6
    End point values
    		 ENR Lurasidone 80 mg ENR Lurasidone 160 mg Placebo
    Number of subjects analysed
    52
    43
    112
    Units: units on a scale
        least squares mean (standard error)
    -0.83 ± 0.143
    -1.31 ± 0.16
    -0.73 ± 0.106
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    ENR Lurasidone 80 mg v Placebo
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.578
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 0.25
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    ENR Lurasidone 160 mg v Placebo
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.96
         upper limit
    		 -0.2

    Other pre-specified: Change from baseline to Week 6 for the lurasidone 20 mg and lurasidone 80 - 160 mg groups compared to the placebo group in the GAF score

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    End point title
    		 Change from baseline to Week 6 for the lurasidone 20 mg and lurasidone 80 - 160 mg groups compared to the placebo group in the GAF score
    End point description
    The GAF is a numeric scale (0 through 100) that measures a patient’s overall level of psychological, social, and occupation functioning. It is designed to guide clinicians through a methodical and comprehensive consideration of all aspects of a patient’s symptoms and functioning. The scale begins at 100 - superior functioning - to 0 - inadequate information.
    End point type
    Other pre-specified
    End point timeframe
    6 Weeks
    End point values
    		 Lurasidone 20 mg Lurasidone 80 mg - 160 mg Placebo
    Number of subjects analysed
    101
    198
    112
    Units: units on a scale
        least squares mean (standard error)
    11.5 ± 1.43
    15.8 ± 1.04
    9.2 ± 1.4
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Lurasidone 20 mg v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.258
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 6.2
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Placebo v Lurasidone 80 mg - 160 mg
    Number of subjects included in analysis
    310
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Slope
    Point estimate
    6.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.2
         upper limit
    		 10.1

    Other pre-specified: Change from baseline to Week 6 for the lurasidone 20 mg and lurasidone 80 - 160 mg groups compared to the placebo group in the Euroqol (EQ-5D) Index score

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    End point title
    		 Change from baseline to Week 6 for the lurasidone 20 mg and lurasidone 80 - 160 mg groups compared to the placebo group in the Euroqol (EQ-5D) Index score
    End point description
    The EQ-5D is a standardized measure of health state consisting of two parts: a) EQ-5D measuring mobility, self-care, pain/discomfort, usual activities, and anxiety/depression on a 0 2 scale with lower scores indicating improvement, and b) a 20-cm visual analogue scale (VAS) for health status rating on a 0-100 scale with higher scores indicating improvement. EQ-5D health states, defined by the EQ-5D descriptive system, may be converted into a single summary index (i.e. the EQ-5D index score) by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. The EQ-5D Index scores ranged from -0.429 to 1.000. Generally higher observed EQ-5D Index scores indicate a better degree of health.
    End point type
    Other pre-specified
    End point timeframe
    6 weeks
    End point values
    		 Lurasidone 20 mg Lurasidone 80 mg - 160 mg Placebo
    Number of subjects analysed
    92
    173
    103
    Units: units on a scale
        least squares mean (standard error)
    0.041 ± 0.024
    0.095 ± 0.018
    -0.042 ± 0.023
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Lurasidone 20 mg v Placebo
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    0.084
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.018
         upper limit
    		 0.149
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Placebo v Lurasidone 80 mg - 160 mg
    Number of subjects included in analysis
    276
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    0.138
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.081
         upper limit
    		 0.194

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 Weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Lurasidone 20 mg
    Reporting group description
    		 Lurasidone: Lurasidone 20 mg once daily

    Reporting group title
    Lurasidone 80-160 mg
    Reporting group description
    		 Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2 (one subject who was randomized was not treated with study drug, therefore, excluded from the safety population).

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo: Once Daily

    Serious adverse events
    		 Lurasidone 20 mg Lurasidone 80-160 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 101 (2.97%)
    6 / 198 (3.03%)
    8 / 112 (7.14%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 198 (0.51%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fibula Fracture
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 198 (0.51%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 198 (0.51%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Therapuetuc Response Delayed
    Additional description: General Disorders and Administration Site conditions
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 198 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    3 / 101 (2.97%)
    3 / 198 (1.52%)
    4 / 112 (3.57%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychotic Disorder
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 198 (1.01%)
    3 / 112 (2.68%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Lurasidone 20 mg Lurasidone 80-160 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 101 (42.57%)
    92 / 198 (46.46%)
    58 / 112 (51.79%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 101 (9.90%)
    11 / 198 (5.56%)
    8 / 112 (7.14%)
         occurrences all number
    18
    12
    12
    Somnolence
         subjects affected / exposed
    5 / 101 (4.95%)
    6 / 198 (3.03%)
    6 / 112 (5.36%)
         occurrences all number
    5
    6
    6
    Akathisia
         subjects affected / exposed
    5 / 101 (4.95%)
    21 / 198 (10.61%)
    2 / 112 (1.79%)
         occurrences all number
    9
    24
    2
    Sedation
         subjects affected / exposed
    3 / 101 (2.97%)
    6 / 198 (3.03%)
    2 / 112 (1.79%)
         occurrences all number
    3
    6
    2
    Tremor
         subjects affected / exposed
    2 / 101 (1.98%)
    6 / 198 (3.03%)
    2 / 112 (1.79%)
         occurrences all number
    2
    6
    2
    Dizziness
         subjects affected / exposed
    1 / 101 (0.99%)
    6 / 198 (3.03%)
    1 / 112 (0.89%)
         occurrences all number
    1
    6
    1
    Parkinsonism
         subjects affected / exposed
    1 / 101 (0.99%)
    6 / 198 (3.03%)
    1 / 112 (0.89%)
         occurrences all number
    1
    6
    1
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    2 / 101 (1.98%)
    5 / 198 (2.53%)
    4 / 112 (3.57%)
         occurrences all number
    2
    5
    5
    Nausea
         subjects affected / exposed
    2 / 101 (1.98%)
    17 / 198 (8.59%)
    4 / 112 (3.57%)
         occurrences all number
    2
    21
    5
    Diarrhoea
         subjects affected / exposed
    2 / 101 (1.98%)
    8 / 198 (4.04%)
    3 / 112 (2.68%)
         occurrences all number
    2
    8
    3
    Constipation
         subjects affected / exposed
    3 / 101 (2.97%)
    6 / 198 (3.03%)
    2 / 112 (1.79%)
         occurrences all number
    4
    9
    2
    Vomiting
         subjects affected / exposed
    0 / 101 (0.00%)
    11 / 198 (5.56%)
    1 / 112 (0.89%)
         occurrences all number
    0
    12
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    16 / 101 (15.84%)
    21 / 198 (10.61%)
    24 / 112 (21.43%)
         occurrences all number
    22
    33
    33
    Agitation
         subjects affected / exposed
    5 / 101 (4.95%)
    9 / 198 (4.55%)
    11 / 112 (9.82%)
         occurrences all number
    5
    9
    14
    Anxiety
         subjects affected / exposed
    8 / 101 (7.92%)
    8 / 198 (4.04%)
    7 / 112 (6.25%)
         occurrences all number
    18
    9
    12
    Restlessness
         subjects affected / exposed
    0 / 101 (0.00%)
    6 / 198 (3.03%)
    4 / 112 (3.57%)
         occurrences all number
    0
    10
    9
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 198 (0.00%)
    4 / 112 (3.57%)
         occurrences all number
    1
    0
    4
    Back Pain
         subjects affected / exposed
    4 / 101 (3.96%)
    3 / 198 (1.52%)
    1 / 112 (0.89%)
         occurrences all number
    4
    3
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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