Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A 6-Week Randomized, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study To Evaluate The Efficacy and Safety of Lurasidone in Adolescent Subjects with Schizophrenia

    Summary
    EudraCT number
    		 2013-001695-38
    Trial protocol
    		 ES   IT   Outside EU/EEA   BG   HU   GB   BE   FR   RO  
    Global end of trial date
    29 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Dec 2016
    First version publication date
    31 Dec 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D1050301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01911429
    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 1-866-503-6351, clinicaltrialsdisclosure@sunovion.com
    Scientific contact
    Medical Director, Sunovion Pharmaceuticals Inc., 001 1-866-503-6351, clinicaltrialsdisclosure@sunovion.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001230-PIP01-11
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    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
    13 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy and Safety study of Lurasidone in pediatric patients.
    Protection of trial subjects
    The study was conducted according to the protocol, International Conference on Harmonisation (ICH) Good Clinical Practice (GCP), ICH guidelines, and the ethical principles that have their origin in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2013
    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
    Colombia: 16
    Country: Number of subjects enrolled
    Russian Federation: 46
    Country: Number of subjects enrolled
    Romania: 16
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    United States: 110
    Country: Number of subjects enrolled
    Philippines: 6
    Country: Number of subjects enrolled
    Ukraine: 74
    Country: Number of subjects enrolled
    Malaysia: 4
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Mexico: 10
    Country: Number of subjects enrolled
    Bulgaria: 24
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 5
    Worldwide total number of subjects
    326
    EEA total number of subjects
    55
    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)
    326
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 male and female subjects 13 to 17, inclusive,with DSM-IV-TR Axis I primary diagnosis of schizophrenia and confirmation of the diagnosis by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children. Positive and Negative Syndrome Scale total score >70 at screening and Baseline; CGI-S > 4 at screening and baseline.

    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 40 mg
    Arm description
    		 Lurasidone 40 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 40 mg once daily

    Arm title
    		 Lurasidone 80 mg
    Arm description
    		 Lurasidone 80 mg once daily Lurasidone 80 mg: Lurasidone 80 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
    lursidone 80mg once daily Subjects received lurasidone 40/mg day from Days 1-3, and 80mg/day from days 4 to Week 6 visit

    Arm title
    		 Placebo
    Arm description
    		 Placebo 40 or 80 mg 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 40 mg Lurasidone 80 mg Placebo
    Started
    108
    104
    112
    Completed
    98
    92
    92
    Not completed
    12
    12
    20
         Consent withdrawn by subject
    5
    5
    4
         Adverse event, non-fatal
    5
    3
    9
         Transferred to other arm/group
    -
    2
    -
         accidental randomization
    -
    -
    1
         Lost to follow-up
    -
    -
    1
         Lack of efficacy
    1
    2
    4
         subject left study
    1
    -
    -
         Protocol deviation
    -
    -
    1
    Joined
    2
    0
    0
         Transferred in from other group/arm
    2
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Lurasidone 40 mg
    Reporting group description
    		 Lurasidone 40 mg once daily

    Reporting group title
    Lurasidone 80 mg
    Reporting group description
    		 Lurasidone 80 mg once daily Lurasidone 80 mg: Lurasidone 80 mg once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo 40 or 80 mg once daily

    Reporting group values
    		 Lurasidone 40 mg Lurasidone 80 mg Placebo Total
    Number of subjects
    		 110 104 112 326
    Age Categorical
    Units: Participants
        <=18 years
    		 110 104 112 326
        Between 18 and 65 years
    		 0 0 0 0
        >=65 years
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15.5 ± 1.33 15.3 ± 1.35 15.3 ± 1.37 -
    Gender, Male/Female
    Units: Participants
        Female
    		 67 70 71 208
        Male
    		 43 34 41 118
    Age, Customized
    Units: Subjects
        13-15 years old
    		 50 55 55 160
        16-17 years old
    		 60 49 57 166
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 13 18 13 44
        Not Hispanic or Latino
    		 97 86 99 282
        Unknown or Not Reported
    		 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 6 4 5 15
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 20 18 22 60
        White
    		 73 73 74 220
        More than one race
    		 11 9 11 31
        Unknown or Not Reported
    		 0 0 0 0
    Region of Enrollment
    Units: Subjects
        North America
    		 38 35 37 110
        South America
    		 9 8 9 26
        Europe
    		 57 57 61 175
        Southeast Asia
    		 4 3 4 11
        East Asia
    		 2 1 1 4
    DSM-IV diagnosis of Schizophrenia
    Units: Subjects
        295.10 schizophrenia, disorganized type
    		 13 6 7 26
        295.30 schizophrenia, paranoid type
    		 88 81 85 254
        295.90 schizophrenia, undifferentiated type
    		 9 17 20 46
    BaselineBMI Percentile
    Units: Subjects
        < 3th percentile
    		 0 1 0 1
        > 3th to 85th percentile
    		 74 65 72 211
        > 85th to 97th percentile
    		 30 32 32 94
        > 97th percentile
    		 6 6 8 20
    Baseline BMI
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 22.38 ± 3.262 22.56 ± 3.497 22.52 ± 3.606 -
    Baseline weight
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 63.5 ± 12.39 63.9 ± 12.88 64 ± 11.88 -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Lurasidone 40 mg
    Reporting group description
    		 Lurasidone 40 mg once daily

    Reporting group title
    Lurasidone 80 mg
    Reporting group description
    		 Lurasidone 80 mg once daily Lurasidone 80 mg: Lurasidone 80 mg once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo 40 or 80 mg once daily

    Primary: change from Baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6.

    		 Close Top of page
    End point title
    		 change from Baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6.
    End point description
    PANNS total score: Changes from baseline over time - mixed model for repeated measures at week 6 LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, PANSS total score at baseline, and treatment-by-visit interaction.
    End point type
    Primary
    End point timeframe
    Baseline to 6 weeks
    End point values
    		 Lurasidone 40 mg Lurasidone 80 mg Placebo
    Number of subjects analysed
    108
    104
    112
    Units: units on a scale
    arithmetic mean (standard deviation)
        baseline
    94.5 ± 10.97
    94 ± 11.12
    92.8 ± 11.08
        Week 6
    -18.6 ± 1.59
    -18.3 ± 1.6
    -10.5 ± 1.59
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Statistical analysis description
    The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses. LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).
    Comparison groups
    Lurasidone 40 mg v Placebo
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 LS mean difference (SE)
    Parameter type
    		 LS mean difference (SE)
    Point estimate
    -8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.4
         upper limit
    		 -3.7
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Statistical analysis description
    The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses. LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).
    Comparison groups
    Lurasidone 80 mg v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006
    Method
    		 LS mean difference (SE)
    Parameter type
    		 LS mean difference (SE)
    Point estimate
    -7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.1
         upper limit
    		 -3.4
    Variability estimate
    Standard deviation

    Secondary: Change from Baseline in Clinical Global Impression severity (CGI-S) scale at Day 4, Weeks 1, 2, 3, 4, 5, and 6

    		 Close Top of page
    End point title
    		 Change from Baseline in Clinical Global Impression severity (CGI-S) scale at Day 4, Weeks 1, 2, 3, 4, 5, and 6
    End point description
    Clinical Global Impression severity (CGI-S): Changes from baseline over time-mixed model for repeated measures LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, CGIS at baseline, and treatment-by-visit interaction.
    End point type
    Secondary
    End point timeframe
    baseline, week 6
    End point values
    		 Lurasidone 40 mg Lurasidone 80 mg Placebo
    Number of subjects analysed
    108
    104
    112
    Units: units on a scale
    arithmetic mean (standard deviation)
        baseline
    4.9 ± 0.62
    4.8 ± 0.66
    4.8 ± 0.61
        week 6
    -0.97 ± 0.093
    -0.92 ± 0.093
    -0.5 ± 0.094
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Statistical analysis description
    LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).
    Comparison groups
    Lurasidone 40 mg v Placebo
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 LS mean difference (SE)
    Parameter type
    		 LS mean difference (SE)
    Point estimate
    -0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.73
         upper limit
    		 -0.22
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Statistical analysis description
    LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).
    Comparison groups
    Lurasidone 80 mg v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0015
    Method
    		 LS mean difference (SE)
    Parameter type
    		 LS mean difference (SE)
    Point estimate
    -0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.67
         upper limit
    		 -0.16
    Variability estimate
    Standard deviation

    Secondary: Change from Baseline in PANSS total score at Day 4, Weeks 1, 2, 3, 4, and 5

    		 Close Top of page
    End point title
    		 Change from Baseline in PANSS total score at Day 4, Weeks 1, 2, 3, 4, and 5
    End point description
    PANSS positive subscale score: changes from baseline over time - mixed model for repeated measures LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.
    End point type
    Secondary
    End point timeframe
    baseline, week 6
    End point values
    		 Lurasidone 40 mg Lurasidone 80 mg Placebo
    Number of subjects analysed
    108
    104
    112
    Units: units on a scale
    arithmetic mean (standard deviation)
        baseline
    24.1 ± 3.96
    24 ± 4.08
    23.4 ± 3.75
        week 6
    -6.3 ± 0.51
    -6.3 ± 0.51
    -3.1 ± 0.51
    No statistical analyses for this end point

    Secondary: Change from Baseline in PANSS positive, negative, general psychopathology, and excitability subscale scores at Day 4, Weeks 1, 2, 3, 4, 5, and 6

    		 Close Top of page
    End point title
    		 Change from Baseline in PANSS positive, negative, general psychopathology, and excitability subscale scores at Day 4, Weeks 1, 2, 3, 4, 5, and 6
    End point description
    PANSS Negative subscale score: changes form baseline over time - Mixed model for repeated measures LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.
    End point type
    Secondary
    End point timeframe
    baseline, week 6
    End point values
    		 Lurasidone 40 mg Lurasidone 80 mg Placebo
    Number of subjects analysed
    108
    104
    112
    Units: units on a scale
    arithmetic mean (standard deviation)
        baseline
    24.2 ± 4.32
    24.5 ± 4.37
    24.4 ± 4.01
        week 6
    -4 ± 0.48
    -3.8 ± 0.49
    -2.3 ± 0.49
    No statistical analyses for this end point

    Secondary: Proportion of responders, where response is based on ≥ 20% improvement from Baseline in PANSS total score at Week 6

    		 Close Top of page
    End point title
    		 Proportion of responders, where response is based on ≥ 20% improvement from Baseline in PANSS total score at Week 6
    End point description
    PANSS responder analysis over time: achieving >= 20% reduction from baseline
    End point type
    Secondary
    End point timeframe
    week 6
    End point values
    		 Lurasidone 40 mg Lurasidone 80 mg Placebo
    Number of subjects analysed
    108
    104
    112
    Units: number of participants
        number (not applicable)
    69
    47
    69
    No statistical analyses for this end point

    Secondary: Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) at Week 6

    		 Close Top of page
    End point title
    		 Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) at Week 6
    End point description
    PQ-LES-Q percentage maximum possible score: summary statistics over time LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach.
    End point type
    Secondary
    End point timeframe
    baseline, week 6
    End point values
    		 Lurasidone 40 mg Lurasidone 80 mg Placebo
    Number of subjects analysed
    108
    104
    112
    Units: units on a scale
    arithmetic mean (standard deviation)
        baseline
    51.3 ± 17.26
    53.6 ± 18.5
    52.5 ± 15.67
        week 6
    5.6 ± 1.28
    6.1 ± 1.3
    0.3 ± 1.24
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinician-rated Children’s Global Assessment Scale (CGAS) at Week 6

    		 Close Top of page
    End point title
    		 Change from Baseline in Clinician-rated Children’s Global Assessment Scale (CGAS) at Week 6
    End point description
    Clinician-rated Children’s Global Assessment Scale (CGAS) score: summary statistics over time LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach.
    End point type
    Secondary
    End point timeframe
    baseline, week 6
    End point values
    		 Lurasidone 40 mg Lurasidone 80 mg Placebo
    Number of subjects analysed
    108
    104
    112
    Units: units on a scale
    arithmetic mean (standard deviation)
        baseline
    44.2 ± 9.33
    44.6 ± 8.11
    43.9 ± 8.34
        week 6
    11.3 ± 1.16
    11.9 ± 1.18
    7.5 ± 1.17
    No statistical analyses for this end point

    Secondary: Change from baseline in PANSS general psychopathology subscale scores

    		 Close Top of page
    End point title
    		 Change from baseline in PANSS general psychopathology subscale scores
    End point description
    PANSS general psychopathology subscale score: changes from baseline over time - mixed model for repeated measures LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.
    End point type
    Secondary
    End point timeframe
    baseline, week 6
    End point values
    		 Lurasidone 40 mg Lurasidone 80 mg Placebo
    Number of subjects analysed
    108
    104
    112
    Units: units on a scale
    arithmetic mean (standard deviation)
        baseline
    46.2 ± 6.65
    45.5 ± 7.03
    45 ± 6.94
        week 6
    -8.1 ± 0.8
    -8.1 ± 0.81
    -5.3 ± 0.8
    No statistical analyses for this end point

    Secondary: Change from baseline in PANSS excitability subscale scores

    		 Close Top of page
    End point title
    		 Change from baseline in PANSS excitability subscale scores
    End point description
    LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.
    End point type
    Secondary
    End point timeframe
    baseline, week 6
    End point values
    		 Lurasidone 40 mg Lurasidone 80 mg Placebo
    Number of subjects analysed
    108
    104
    112
    Units: units on a scale
    arithmetic mean (standard deviation)
        baseline
    10.8 ± 2.91
    11.1 ± 3.07
    10.7 ± 3.23
        week 6
    -0.6 ± 0.33
    -1.7 ± 0.33
    -2.4 ± 0.33
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
    Adverse event reporting additional description
    AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Lurasidone 40 mg
    Reporting group description
    		 Lurasidone 40 mg once daily Lurasidone 40 mg: Lurasidone 40 mg once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo 40 or 80 mg once daily Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily

    Reporting group title
    Lurasidone 80 mg
    Reporting group description
    		 Lurasidone 80 mg once daily Lurasidone 80 mg: Lurasidone 80 mg once daily

    Serious adverse events
    		 Lurasidone 40 mg Placebo Lurasidone 80 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 110 (3.64%)
    9 / 112 (8.04%)
    2 / 104 (1.92%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    schizophrenia
         subjects affected / exposed
    2 / 110 (1.82%)
    7 / 112 (6.25%)
    2 / 104 (1.92%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Homicidal Ideation
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychotic Disorder
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
    0 / 104 (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
    Suicidal Ideation
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
    0 / 104 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Lurasidone 40 mg Placebo Lurasidone 80 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    70 / 110 (63.64%)
    53 / 112 (47.32%)
    67 / 104 (64.42%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 110 (6.36%)
    14 / 112 (12.50%)
    11 / 104 (10.58%)
         occurrences all number
    8
    19
    15
    Somnolence
         subjects affected / exposed
    10 / 110 (9.09%)
    6 / 112 (5.36%)
    12 / 104 (11.54%)
         occurrences all number
    10
    8
    12
    Sedation
         subjects affected / exposed
    6 / 110 (5.45%)
    2 / 112 (1.79%)
    2 / 104 (1.92%)
         occurrences all number
    6
    2
    3
    Akathisia
         subjects affected / exposed
    10 / 110 (9.09%)
    2 / 112 (1.79%)
    9 / 104 (8.65%)
         occurrences all number
    12
    2
    10
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    14 / 110 (12.73%)
    3 / 112 (2.68%)
    15 / 104 (14.42%)
         occurrences all number
    20
    4
    18
    Vomiting
         subjects affected / exposed
    9 / 110 (8.18%)
    2 / 112 (1.79%)
    7 / 104 (6.73%)
         occurrences all number
    10
    2
    8
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 110 (5.45%)
    10 / 112 (8.93%)
    7 / 104 (6.73%)
         occurrences all number
    6
    12
    8
    Agitation
         subjects affected / exposed
    5 / 110 (4.55%)
    5 / 112 (4.46%)
    6 / 104 (5.77%)
         occurrences all number
    7
    5
    6
    Anxiety
         subjects affected / exposed
    11 / 110 (10.00%)
    9 / 112 (8.04%)
    3 / 104 (2.88%)
         occurrences all number
    14
    11
    3

    More information

    		 Close Top of page

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 08:51:40 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA