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    Clinical Trial Results:
    A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED WITHDRAWAL STUDY OF LURASIDONE FOR THE MAINTENANCE TREATMENT OF SUBJECTS WITH SCHIZOPHRENIA

    Summary
    EudraCT number
    		 2011-001711-31
    Trial protocol
    		 SK   IT  
    Global end of trial date
    06 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Oct 2016
    First version publication date
    02 Oct 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D1050238
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01435928
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sunovion Pharmaceuticals Inc.
    Sponsor organisation address
    One Bridge Plaza North, Suite 510, Ft. Lee, United States, 07024
    Public contact
    Medical Director, CNS, Sunovion Pharmaceuticals Inc., 001 866-503-6351, clinicaltrialdisclosure@sunovion.com
    Scientific contact
    Medical Director, CNS, Sunovion Pharmaceuticals Inc., 001 866-503-6351, 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
    20 Jan 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of lurasidone for the maintenance treatment of subjects with schizophrenia.
    Protection of trial subjects
    This 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
    10 Oct 2011
    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
    France: 8
    Country: Number of subjects enrolled
    Serbia: 40
    Country: Number of subjects enrolled
    United States: 532
    Country: Number of subjects enrolled
    Slovakia: 35
    Country: Number of subjects enrolled
    Russian Federation: 24
    Country: Number of subjects enrolled
    South Africa: 36
    Country: Number of subjects enrolled
    Italy: 1
    Worldwide total number of subjects
    676
    EEA total number of subjects
    44
    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)
    671
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 hospitalized patients and outpatients were assessed for eligibility and upon meeting entry criteria, were tapered off their psychotropic medications in a manner consistent with labeling recommendations and usual medical practice. A total of up to 14 days within the screening/washout phase were allowed to taper as needed

    Period 1
    Period 1 title
    Open Label Phase - up to 24 Weeks
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All Subjects
    Arm description
    		 During the Open Label Phase subjects will receive Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
    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 and 80 mg, once daily in the evening with a meal or 30 minutes after eating

    Number of subjects in period 1
    		All Subjects
    Started
    676
    Completed
    287
    Not completed
    389
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    96
         did not meet stabilization criteria
    44
         Administrative
    14
         Adverse event, non-fatal
    83
         Lost to follow-up
    60
         Lack of efficacy
    46
         Protocol deviation
    39
         Terminated at study completion
    6
    Period 2
    Period 2 title
    Double Blind Phase - 28 Weeks
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lurasidone
    Arm description
    		 During double blind phase subjects received Lurasidone flexibly dosed 40 or 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
    Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating

    Arm title
    		 Placebo
    Arm description
    		 During double blind phase subjects received matching placebo.
    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 in the evening with a meal or 30 minutes after eating

    Number of subjects in period 2 [1]
    		Lurasidone Placebo
    Started
    144
    141
    Completed
    28
    20
    Not completed
    116
    121
         Consent withdrawn by subject
    5
    12
         Administrative
    5
    2
         Adverse event, non-fatal
    3
    1
         Relapse criteria met
    43
    58
         Lost to follow-up
    2
    5
         Protocol deviation
    11
    4
         Terminated at study completion
    47
    39
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Of the 287 subjects who completed the open-label phase, 2 subjects were not randomized to the double-blind phase (1 subject due to not meeting the criteria for clinical stability, and 1 subject due to an AE), thus only 285 subjects were randomized to the double blind phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    		 During the Open Label Phase subjects will receive Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating

    Reporting group values
    		 All Subjects Total
    Number of subjects
    		 676 676
    Age Categorical
    Units: participants
        <=18 years
    		 0 0
        Between 18 and 65 years
    		 671 671
        >=65 years
    		 5 5
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.6 ± 11.85 -
    Gender, Male/Female
    Units: participants
        Female
    		 465 465
        Male
    		 211 211
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 7 7
        Asian
    		 4 4
        Native Hawaiian or Other Pacific Islander
    		 2 2
        Black or African American
    		 353 353
        White
    		 286 286
        More than one race
    		 0 0
        Unknown or Not Reported
    		 24 24
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 41 41
        Not Hispanic or Latino
    		 635 635
        Unknown or Not Reported
    		 0 0
    Region of Enrollment
    Units: Subjects
        France
    		 8 8
        Serbia
    		 40 40
        United States
    		 532 532
        Slovakia
    		 35 35
        Russian Federation
    		 24 24
        South Africa
    		 36 36
        Italy
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    		 During the Open Label Phase subjects will receive Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
    Reporting group title
    Lurasidone
    Reporting group description
    		 During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily

    Reporting group title
    Placebo
    Reporting group description
    		 During double blind phase subjects received matching placebo.

    Primary: Time to First Relapse Event During Double-blind phase

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    End point title
    		 Time to First Relapse Event During Double-blind phase
    End point description
    End point type
    Primary
    End point timeframe
    Double-blind phase -28 weeks
    End point values
    		 Lurasidone Placebo
    Number of subjects analysed
    144
    141
    Units: number of relapsed subjects
    43
    58
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Lurasidone v Placebo
    Number of subjects included in analysis
    285
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.039
    Method
    		 Logrank
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 0.98

    Secondary: Change from Double-blind Baseline in Positive and Negative Syndrome Scale (PANSS) Total score

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    End point title
    		 Change from Double-blind Baseline in Positive and Negative Syndrome Scale (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 and three scales: the Positive scale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative scale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. 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
    Double-Blind phase - 28 Weeks
    End point values
    		 Lurasidone Placebo
    Number of subjects analysed
    144
    141
    Units: units on a scale
        least squares mean (standard error)
    8.3 ± 1.33
    12.4 ± 1.33
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Lurasidone v Placebo
    Number of subjects included in analysis
    285
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.029
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - LOCF

    Secondary: Change from Double-blind Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) score

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    End point title
    		 Change from Double-blind Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) score
    End point description
    The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.
    End point type
    Secondary
    End point timeframe
    Double-blind phase - 28 Weeks
    End point values
    		 Lurasidone Placebo
    Number of subjects analysed
    144
    141
    Units: units on a scale
        least squares mean (standard error)
    0.44 ± 0.087
    0.74 ± 0.087
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Lurasidone v Placebo
    Number of subjects included in analysis
    285
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.015
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [2] - LOCF

    Secondary: Change from Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score

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    End point title
    		 Change from Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (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
    Double-blind phase - 28 Weeks
    End point values
    		 Lurasidone Placebo
    Number of subjects analysed
    140
    139
    Units: units on a scale
        least squares mean (standard error)
    2.5 ± 0.63
    3.6 ± 0.63
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Placebo v Lurasidone
    Number of subjects included in analysis
    279
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.218 [3]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [3] - LOCF

    Secondary: Change from Double-blind Baseline in Short Form-12v2 Health Survey (SF-12v2) Physical Component Score

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    End point title
    		 Change from Double-blind Baseline in Short Form-12v2 Health Survey (SF-12v2) Physical Component Score
    End point description
    The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
    End point type
    Secondary
    End point timeframe
    Double-blind phase - 28 Weeks
    End point values
    		 Lurasidone Placebo
    Number of subjects analysed
    139
    138
    Units: units on a scale
        least squares mean (standard error)
    0.398 ± 0.5354
    -1.341 ± 0.5373
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Lurasidone v Placebo
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021 [4]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [4] - LOCF

    Secondary: Change from Double-blind Baseline in Modified Specific Levels of Functioning (SLOF) total score

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    End point title
    		 Change from Double-blind Baseline in Modified Specific Levels of Functioning (SLOF) total score
    End point description
    The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items divided into two subscales: Social functioning (comprised of 7 items from interpersonal relationships section) and Community Living Skills (comprised of 17 items from activities and work skills sections). Each item is rated on a 5-point scale and mapped to 0 to 4 with a higher score indicating worse condition. The total score will be the sum of all 24 items and ranges from 0 to 96.
    End point type
    Secondary
    End point timeframe
    Double-blind phase - 28 Weeks
    End point values
    		 Lurasidone Placebo
    Number of subjects analysed
    125
    121
    Units: units on a scale
        least squares mean (standard error)
    0.8 ± 0.88
    3.2 ± 0.89
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    Lurasidone v Placebo
    Number of subjects included in analysis
    246
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.056
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [5] - LOCF

    Secondary: Brief Adherence Rating Scale

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    End point title
    		 Brief Adherence Rating Scale
    End point description
    The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 - 100%) of doses taken by the subject in the previous month.
    End point type
    Secondary
    End point timeframe
    Double-blind phase - 28 Weeks
    End point values
    		 Lurasidone Placebo
    Number of subjects analysed
    138
    139
    Units: percentage of monthly doses taken
        arithmetic mean (standard deviation)
    98.8 ± 4.42
    98.9 ± 3.66
    No statistical analyses for this end point

    Secondary: Smoking Questionnaire (Average Number of Cigarettes Per Day) at Week 28 (LOCF)

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    End point title
    		 Smoking Questionnaire (Average Number of Cigarettes Per Day) at Week 28 (LOCF)
    End point description
    Smoking history and frequency were assessed during the study by a research staff member. During the study, smoked subjects were asked about the average number of cigarettes per day they smoked over the last week.
    End point type
    Secondary
    End point timeframe
    28 Weeks - Double Blind Phase
    End point values
    		 Lurasidone Placebo
    Number of subjects analysed
    47
    49
    Units: number of cigarettes smoked daily
        arithmetic mean (standard deviation)
    10 ± 12.76
    8.2 ± 8.97
    No statistical analyses for this end point

    Secondary: Intent to Attend (ITA) Assessment at Open-label Baseline

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    End point title
    		 Intent to Attend (ITA) Assessment at Open-label Baseline
    End point description
    The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = “Not at all” and 9 = “Extremely”. The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the screening visit: “How likely is it that you will complete the study?”
    End point type
    Secondary
    End point timeframe
    Open Label Baseline
    End point values
    		 Lurasidone Placebo
    Number of subjects analysed
    143
    140
    Units: units on a scale
        arithmetic mean (standard deviation)
    7.9 ± 14.8
    8 ± 1.47
    No statistical analyses for this end point

    Secondary: Time to all-cause discontinuation

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    End point title
    		 Time to all-cause discontinuation
    End point description
    End point type
    Secondary
    End point timeframe
    Double-blind phase - 28 weeks
    End point values
    		 Lurasidone Placebo
    Number of subjects analysed
    144
    141
    Units: number of discontinued subjects
    69
    82
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Lurasidone
    Number of subjects included in analysis
    285
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.07
    Method
    		 Logrank
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.03

    Other pre-specified: EuroQol (EQ-5D): EQ-VAS Score

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    End point title
    		 EuroQol (EQ-5D): EQ-VAS Score
    End point description
    The EQ-5D is a self-administered, standardized measure of health states consisting of two parts: EQ-5D descriptive system consisting of one question in each of five dimensions (mobility, self-care, pain, usual activities, and anxiety) with three possible response levels per question, classifying patients into one of 243 distinct health states, and a 20-cm visual analogue health status rating. The 20-cm visual analog scale (VAS) has endpoints labeled "best imaginable health state" and "worst imaginable health state" that are anchored at 100 and 0, respectively. Respondents are asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS, which best represents their own health on that day.
    End point type
    Other pre-specified
    End point timeframe
    Double-blind phase - 28 Weeks
    End point values
    		 Lurasidone Placebo
    Number of subjects analysed
    139
    138
    Units: units on a scale
        arithmetic mean (standard deviation)
    74.5 ± 19.87
    68.2 ± 28.59
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For the open label phase - all subjects SAEs and AEs were reported over 24 weeks. For the double blind phase, lurasidone and placebo, SAEs and AEs were reported over 28 weeks. The study was stopped once the anticipated number of relapses were reached.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    		 During the Open Label Phase subjects will receive Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating

    Reporting group title
    Placebo
    Reporting group description
    		 During double blind phase subjects received matching placebo.

    Reporting group title
    Lurasidone
    Reporting group description
    		 During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily

    Serious adverse events
    		 All Subjects Placebo Lurasidone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    59 / 676 (8.73%)
    11 / 141 (7.80%)
    6 / 144 (4.17%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Intentional overdose
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (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
    Overdose
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (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
    Radius fracture
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (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
    Toxicity to various agents
         subjects affected / exposed
    0 / 676 (0.00%)
    0 / 141 (0.00%)
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 676 (0.00%)
    1 / 141 (0.71%)
    0 / 144 (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
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 676 (0.00%)
    1 / 141 (0.71%)
    0 / 144 (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
    Artial fibrillation
         subjects affected / exposed
    0 / 676 (0.00%)
    1 / 141 (0.71%)
    0 / 144 (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
    Nervous system disorders
    Akathasia
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 676 (0.00%)
    0 / 141 (0.00%)
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischemic attach
         subjects affected / exposed
    0 / 676 (0.00%)
    0 / 141 (0.00%)
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drug ineffective
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Therapeutic response delayed
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 676 (0.00%)
    1 / 141 (0.71%)
    0 / 144 (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
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (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
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (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
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (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
    Respiratory failure
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (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
    Asthma
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (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
    Dyspnoea
         subjects affected / exposed
    0 / 676 (0.00%)
    0 / 141 (0.00%)
    1 / 144 (0.69%)
         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
    20 / 676 (2.96%)
    4 / 141 (2.84%)
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    5 / 20
    2 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    11 / 676 (1.63%)
    2 / 141 (1.42%)
    2 / 144 (1.39%)
         occurrences causally related to treatment / all
    2 / 11
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    3 / 676 (0.44%)
    0 / 141 (0.00%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    2 / 676 (0.30%)
    0 / 141 (0.00%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute psychosis
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (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
    Aggression
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (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
    Agitation
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (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
    Hallucination, auditory
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Homicidal ideation
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (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
    Hostility
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (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 decompensation
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Substance induced psychotic disorder
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (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
    Suicide attempt
         subjects affected / exposed
    1 / 676 (0.15%)
    1 / 141 (0.71%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    2 / 676 (0.30%)
    0 / 141 (0.00%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pin in extremity
         subjects affected / exposed
    0 / 676 (0.00%)
    0 / 141 (0.00%)
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponytremia
         subjects affected / exposed
    1 / 676 (0.15%)
    0 / 141 (0.00%)
    0 / 144 (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
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 All Subjects Placebo Lurasidone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    373 / 676 (55.18%)
    47 / 141 (33.33%)
    46 / 144 (31.94%)
    Investigations
    Weight increased
         subjects affected / exposed
    14 / 676 (2.07%)
    4 / 141 (2.84%)
    5 / 144 (3.47%)
         occurrences all number
    14
    4
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    77 / 676 (11.39%)
    5 / 141 (3.55%)
    4 / 144 (2.78%)
         occurrences all number
    116
    8
    5
    Akathisia
         subjects affected / exposed
    94 / 676 (13.91%)
    4 / 141 (2.84%)
    3 / 144 (2.08%)
         occurrences all number
    104
    4
    3
    Dystonia
         subjects affected / exposed
    21 / 676 (3.11%)
    1 / 141 (0.71%)
    2 / 144 (1.39%)
         occurrences all number
    23
    1
    2
    Somnolence
         subjects affected / exposed
    34 / 676 (5.03%)
    0 / 141 (0.00%)
    0 / 144 (0.00%)
         occurrences all number
    38
    0
    0
    Dizziness
         subjects affected / exposed
    24 / 676 (3.55%)
    0 / 141 (0.00%)
    1 / 144 (0.69%)
         occurrences all number
    28
    0
    1
    Sedation
         subjects affected / exposed
    25 / 676 (3.70%)
    0 / 141 (0.00%)
    1 / 144 (0.69%)
         occurrences all number
    27
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    69 / 676 (10.21%)
    1 / 141 (0.71%)
    3 / 144 (2.08%)
         occurrences all number
    79
    1
    3
    Vomiting
         subjects affected / exposed
    36 / 676 (5.33%)
    0 / 141 (0.00%)
    1 / 144 (0.69%)
         occurrences all number
    45
    0
    1
    Abdominal discomfort
         subjects affected / exposed
    21 / 676 (3.11%)
    0 / 141 (0.00%)
    0 / 144 (0.00%)
         occurrences all number
    31
    0
    0
    Toothache
         subjects affected / exposed
    22 / 676 (3.25%)
    2 / 141 (1.42%)
    4 / 144 (2.78%)
         occurrences all number
    22
    2
    5
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    62 / 676 (9.17%)
    10 / 141 (7.09%)
    9 / 144 (6.25%)
         occurrences all number
    82
    12
    10
    Anxiety
         subjects affected / exposed
    35 / 676 (5.18%)
    4 / 141 (2.84%)
    6 / 144 (4.17%)
         occurrences all number
    43
    4
    7
    Agitation
         subjects affected / exposed
    21 / 676 (3.11%)
    4 / 141 (2.84%)
    3 / 144 (2.08%)
         occurrences all number
    22
    5
    3
    Schizophrenia
         subjects affected / exposed
    4 / 676 (0.59%)
    11 / 141 (7.80%)
    10 / 144 (6.94%)
         occurrences all number
    4
    11
    11
    Psychotic disorder
         subjects affected / exposed
    4 / 676 (0.59%)
    6 / 141 (4.26%)
    4 / 144 (2.78%)
         occurrences all number
    4
    6
    4
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    17 / 676 (2.51%)
    3 / 141 (2.13%)
    6 / 144 (4.17%)
         occurrences all number
    21
    3
    7
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    28 / 676 (4.14%)
    1 / 141 (0.71%)
    2 / 144 (1.39%)
         occurrences all number
    32
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    23 / 676 (3.40%)
    1 / 141 (0.71%)
    1 / 144 (0.69%)
         occurrences all number
    23
    1
    1

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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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    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
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