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    Clinical Trial Results:
    A Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Subjects with Schizophrenia

    Summary
    EudraCT number
    		 2019-000470-36
    Trial protocol
    		 BG  
    Global end of trial date
    12 Sep 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    31 Oct 2024
    First version publication date
    02 Oct 2024
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    The sentence "p-value is adjusted one‑sided, calculated by Hochberg‑based gatekeeping. " under the p-values (0.403 and 0.331) for CGI-S should be removed since the 2 p-values are nominal p-values, not adjusted p-values per Table 21 in 301 CSR

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SEP361-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04072354
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Otsuka Pharmaceutical Development & Commercialization, Inc.
    Sponsor organisation address
    2440 Research Boulevard, Rockville, United States, 20850
    Public contact
    Clinical Transparency, Otsuka Pharmaceutical Development & Commercialization, Inc., 1 1 8446878522 , clinicaltransparency@otsuka-us.com
    Scientific contact
    Clinical Transparency, Otsuka Pharmaceutical Development & Commercialization, Inc., 1 8446878522, clinicaltransparency@otsuka-us.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002589-PIP01-19
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Sep 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the efficacy of fixed doses of SEP-363856 (50 and 75 mg/day) compared with placebo in acutely psychotic adult subjects with schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) total score. Adolescent subjects were included in order to evaluate the consistency of treatment effects between adult and adolescent subjects and for the characterization of safety profile in this age group.
    Protection of trial subjects
    Written informed consent, assent, or both were obtained from a legally acceptable representative (e.g., guardian) or from the subject.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Sep 2019
    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
    Bulgaria: 54
    Country: Number of subjects enrolled
    Serbia: 136
    Country: Number of subjects enrolled
    Ukraine: 78
    Country: Number of subjects enrolled
    United States: 140
    Country: Number of subjects enrolled
    Russian Federation: 55
    Worldwide total number of subjects
    463
    EEA total number of subjects
    54
    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)
    28
    Adults (18-64 years)
    435
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects took part in the study at investigational sites in the United States, Russia, Ukraine, Bulgaria, and Serbia from 17 September 2019 to 12 September 2023. Sumitomo Pharma America Inc. was the former Sponsor and conducted this study.

    Pre-assignment
    Screening details
    		 A total of 628 subjects were screened, of which 463 subjects (435 adults and 28 adolescents) were randomised to receive SEP-363856 50mg, 75 mg or placebo. Sumitomo was responsible for analysis and clinical study report (CSR) completion. Otsuka took over study after IND was transferred and is concluding activities with registry postings.

    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, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adults: Placebo
    Arm description
    		 Subjects received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matched SEP-363856 placebo tablet, orally, once daily up to Week 6

    Arm title
    		 Adults: SEP-363856 50mg
    Arm description
    		 Subjects received SEP-363856 50 milligrams (mg) tablet, orally, once daily up to Week 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SEP-363856 50mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SEP-363856 50mg tablet, orally, once daily up to Week 6

    Arm title
    		 Adults: SEP-363856 75mg
    Arm description
    		 Subjects received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SEP-363856 75mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SEP-363856 75mg tablet, orally, once daily up to Week 6

    Arm title
    		 Adolescents: Placebo
    Arm description
    		 Subjects received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matched SEP-363856 placebo tablet, orally, once daily up to Week 6

    Arm title
    		 Adolescents: SEP-363856 50mg
    Arm description
    		 Subjects received SEP-363856 50 mg tablet, orally, once daily up to Week 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SEP-363856 50mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SEP-363856 50mg tablet, orally, once daily up to Week 6

    Arm title
    		 Adolescents: SEP-363856 75 mg
    Arm description
    		 Subjects received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SEP-363856 75mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SEP-363856 75mg tablet, orally, once daily up to Week 6

    Number of subjects in period 1
    		Adults: Placebo Adults: SEP-363856 50mg Adults: SEP-363856 75mg Adolescents: Placebo Adolescents: SEP-363856 50mg Adolescents: SEP-363856 75 mg
    Started
    146
    144
    145
    10
    9
    9
    Completed
    119
    110
    118
    10
    8
    8
    Not completed
    27
    34
    27
    0
    1
    1
         Adverse event
    6
    18
    11
    -
    -
    -
         Covid-19 Related
    -
    1
    1
    -
    -
    -
         Withdrawal by Subject
    13
    10
    10
    -
    -
    -
         Withdrawn by subject
    -
    -
    -
    -
    -
    1
         Covid-19 Related adverse event
    2
    -
    -
    -
    -
    -
         Reason not specified
    -
    1
    -
    -
    -
    -
         Lack of efficacy
    5
    4
    5
    -
    1
    -
         Protocol deviation
    1
    -
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adults: Placebo
    Reporting group description
    		 Subjects received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.

    Reporting group title
    Adults: SEP-363856 50mg
    Reporting group description
    		 Subjects received SEP-363856 50 milligrams (mg) tablet, orally, once daily up to Week 6.

    Reporting group title
    Adults: SEP-363856 75mg
    Reporting group description
    		 Subjects received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.

    Reporting group title
    Adolescents: Placebo
    Reporting group description
    		 Subjects received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.

    Reporting group title
    Adolescents: SEP-363856 50mg
    Reporting group description
    		 Subjects received SEP-363856 50 mg tablet, orally, once daily up to Week 6.

    Reporting group title
    Adolescents: SEP-363856 75 mg
    Reporting group description
    		 Subjects received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.

    Reporting group values
    		 Adults: Placebo Adults: SEP-363856 50mg Adults: SEP-363856 75mg Adolescents: Placebo Adolescents: SEP-363856 50mg Adolescents: SEP-363856 75 mg Total
    Number of subjects
    		 146 144 145 10 9 9 463
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.7 ( 10.33 ) 36.1 ( 9.38 ) 37.0 ( 10.23 ) 15.5 ( 1.43 ) 14.8 ( 1.39 ) 15.0 ( 1.41 ) -
    Gender categorical
    Units: Subjects
        Female
    		 73 46 59 4 5 3 190
        Male
    		 73 98 86 6 4 6 273
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 5 3 0 1 0 12
        Not Hispanic or Latino
    		 143 139 142 10 8 9 451
        Unknown or Not Reported
    		 0 0 0 0 0 0 0
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 1 0 0 1
        Asian
    		 2 1 0 1 0 0 4
        Native Hawaiian or Other Pacific Islander
    		 0 0 1 0 0 0 1
        Black or African American
    		 30 30 33 5 5 6 109
        White
    		 114 113 111 3 3 2 346
        More than one race
    		 0 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 1 1 2
    PANSS Total Score
    Units: Units on scale
        arithmetic mean (standard deviation)
    		 101.9 ( 10.56 ) 102.3 ( 10.02 ) 101.7 ( 10.09 ) 96.0 ( 10.51 ) 104.6 ( 14.57 ) 97.9 ( 8.16 ) -

    End points

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    End points reporting groups
    Reporting group title
    Adults: Placebo
    Reporting group description
    		 Subjects received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.

    Reporting group title
    Adults: SEP-363856 50mg
    Reporting group description
    		 Subjects received SEP-363856 50 milligrams (mg) tablet, orally, once daily up to Week 6.

    Reporting group title
    Adults: SEP-363856 75mg
    Reporting group description
    		 Subjects received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.

    Reporting group title
    Adolescents: Placebo
    Reporting group description
    		 Subjects received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.

    Reporting group title
    Adolescents: SEP-363856 50mg
    Reporting group description
    		 Subjects received SEP-363856 50 mg tablet, orally, once daily up to Week 6.

    Reporting group title
    Adolescents: SEP-363856 75 mg
    Reporting group description
    		 Subjects received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.

    Primary: Change From Baseline in PANSS Total Score at Week 6

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    End point title
    		 Change From Baseline in PANSS Total Score at Week 6 [1]
    End point description
    PANSS an interview-based assessment comprised of 30 items & 3 subscales.Positive subscale assessed hallucinations, delusions & related symptoms;Negative subscale assessed emotional withdrawal, lack of motivation & similar symptoms;General Psychopathology assessed anxiety, somatic concern & disorientation. Anchored Likert scale from 1-7, where values of 2 & above indicated presence of progressively more severe symptoms was used to score each item. Individual items were then summed to determine scores for 3 subscales & a total score. PANSS total score ranges from: 30-210, higher score indicates greater severity. Negative change from baseline indicates improvement. mITT population included all randomised subjects that received atleast 1 dose of study drug & had a baseline & at least 1 post-baseline efficacy measurement in PANSS or CGI-S. This outcome measure was only assessed in Adult population. Number of subjects analysed are subjects with data available at specified timepoint.
    End point type
    Primary
    End point timeframe
    Baseline, Week 6
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As pre-specified in protocol the change from baseline in PANSS total score at week 6 was assessed in adult subjects only.
    End point values
    		 Adults: Placebo Adults: SEP-363856 50mg Adults: SEP-363856 75mg
    Number of subjects analysed
    145
    142
    145
    Units: score on a scale
        least squares mean (standard error)
    -19.3 ( 1.55 )
    -16.9 ( 1.57 )
    -19.6 ( 1.56 )
    Statistical analysis title
    		 Change From Baseline in PANSS Total Score
    Comparison groups
    Adults: Placebo v Adults: SEP-363856 50mg
    Number of subjects included in analysis
    287
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.886 [2]
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 Least Square (LS) Mean Difference
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 6.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.2
    Notes
    [2] - P-value was analysed by MMRM method with fixed effects for treatment, visit (as a categorical variable), country, baseline PANSS total score, and treatment‑by‑visit interaction. p-value is adjusted one‑sided, calculated by Hochberg‑based gatekeeping
    Statistical analysis title
    		 Change From Baseline PANSS Total Score
    Comparison groups
    Adults: SEP-363856 75mg v Adults: Placebo
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.842 [3]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 4
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.19
    Notes
    [3] - P-value was analysed by MMRM method with fixed effects for treatment, visit (as a categorical variable), country, baseline PANSS total score, and treatment‑by‑visit interaction. p-value is adjusted one‑sided, calculated by Hochberg‑based gatekeeping.

    Secondary: Change From Baseline in CGI-S Total Score at Week 6

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    End point title
    		 Change From Baseline in CGI-S Total Score at Week 6 [4]
    End point description
    The CGI-S was a single-item clinician-rated assessment of the subject’s current illness state on a 7-point scale (score range: 1-7), where a higher score was associated with greater illness severity. The mITT population included all randomised subjects that received at least 1 dose of study drug, and had a baseline and at least 1 post-baseline efficacy measurement in PANSS or CGI-S. This outcome measure was only assessed in Adult population. Number of subjects analysed are the subjects with data available at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As pre-specified in protocol the change from baseline in CGI-S total score at week 6 was assessed in adult subjects only.
    End point values
    		 Adults: Placebo Adults: SEP-363856 50mg Adults: SEP-363856 75mg
    Number of subjects analysed
    145
    142
    145
    Units: Score
        least squares mean (standard error)
    -0.90 ( 0.085 )
    -0.80 ( 0.086 )
    -1.01 ( 0.086 )
    Statistical analysis title
    		 Change From Baseline in CGI-S Score
    Comparison groups
    Adults: Placebo v Adults: SEP-363856 50mg
    Number of subjects included in analysis
    287
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.403 [5]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.14
         upper limit
    		 0.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.121
    Notes
    [5] - P-value was analysed by MMRM method with fixed effects for treatment, visit (as a categorical variable), country, baseline CGI-S score, and treatment‑by‑visit interaction.
    Statistical analysis title
    		 Change From Baseline in CGI-S Score
    Comparison groups
    Adults: Placebo v Adults: SEP-363856 75mg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.331 [6]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.35
         upper limit
    		 0.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [6] - P-value was analysed by MMRM method with fixed effects for treatment, visit (as a categorical variable), country, baseline CGI-S score, and treatment‑by‑visit interaction.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
    Adverse event reporting additional description
    Safety population included all randomised subjects that received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Adults: Placebo
    Reporting group description
    		 Subjects received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.

    Reporting group title
    Adults: SEP-363856 50mg
    Reporting group description
    		 Subjects received SEP-363856 50 mg tablet, orally, once daily up to Week 6.

    Reporting group title
    Adults: SEP-363856 75mg
    Reporting group description
    		 Subjects received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.

    Reporting group title
    Adolescents: Placebo
    Reporting group description
    		 Subjects received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.

    Reporting group title
    Adolescents: SEP-363856 50mg
    Reporting group description
    		 Subjects received SEP-363856 50 mg tablet, orally, once daily up to Week 6.

    Reporting group title
    Adolescents: SEP-363856 75mg
    Reporting group description
    		 Subjects received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.

    Serious adverse events
    		 Adults: Placebo Adults: SEP-363856 50mg Adults: SEP-363856 75mg Adolescents: Placebo Adolescents: SEP-363856 50mg Adolescents: SEP-363856 75mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 146 (2.74%)
    11 / 144 (7.64%)
    12 / 145 (8.28%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Nerve injury
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    1 / 145 (0.69%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    1 / 145 (0.69%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    1 / 145 (0.69%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drug ineffective
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 144 (0.69%)
    0 / 145 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    3 / 146 (2.05%)
    10 / 144 (6.94%)
    12 / 145 (8.28%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 10
    1 / 12
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Corona virus infection
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adults: Placebo Adults: SEP-363856 50mg Adults: SEP-363856 75mg Adolescents: Placebo Adolescents: SEP-363856 50mg Adolescents: SEP-363856 75mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 146 (28.08%)
    55 / 144 (38.19%)
    50 / 145 (34.48%)
    3 / 10 (30.00%)
    5 / 9 (55.56%)
    6 / 9 (66.67%)
    Investigations
    Weight decreased
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    9 / 146 (6.16%)
    17 / 144 (11.81%)
    17 / 145 (11.72%)
    1 / 10 (10.00%)
    2 / 9 (22.22%)
    2 / 9 (22.22%)
         occurrences all number
    10
    18
    19
    1
    2
    2
    Somnolence
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Constipation
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    11 / 146 (7.53%)
    12 / 144 (8.33%)
    10 / 145 (6.90%)
    0 / 10 (0.00%)
    2 / 9 (22.22%)
    1 / 9 (11.11%)
         occurrences all number
    11
    13
    10
    0
    2
    2
    Vomiting
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Psychiatric disorders
    Abnormal dreams
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Agitation
         subjects affected / exposed
    7 / 146 (4.79%)
    8 / 144 (5.56%)
    11 / 145 (7.59%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    7
    12
    17
    0
    0
    1
    Schizophrenia
         subjects affected / exposed
    4 / 146 (2.74%)
    16 / 144 (11.11%)
    13 / 145 (8.97%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
         occurrences all number
    4
    17
    15
    0
    1
    1
    Anxiety
         subjects affected / exposed
    7 / 146 (4.79%)
    11 / 144 (7.64%)
    11 / 145 (7.59%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    8
    13
    13
    0
    0
    0
    Insomnia
         subjects affected / exposed
    11 / 146 (7.53%)
    16 / 144 (11.11%)
    9 / 145 (6.21%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    15
    21
    12
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 144 (0.00%)
    0 / 145 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jul 2019
    An adolescent cohort was added based on feedback from the Food and Drug Administration (FDA).
    16 Sep 2020
    1. For the Montgomery-Asberg Depression Rating Scale (MADRS), Brief Negative Symptom Scale (BNSS), and University of California San Diego Performance-based Skills Assessment – Brief Version (UPSA-B), the specificity of “total score” was removed from the objectives and left for discussion under the endpoints and analysis sections. 2. Added tobacco use endpoint to align with the assessments collected per the Schedule of Assessments and planned analyses. 3. Inclusion/exclusion criteria were updated.
    26 Jan 2021
    1. A comparative interim analysis for unblinded sample size re-estimation was added for adult subjects only. 2. The purpose of the interim analysis was to assess the need for a sample size increase. 3. Inclusion/exclusion criteria were updated.
    13 Oct 2022
    1. Inclusion/exclusion criteria were updated. 2. Clarified the language regarding duration of hospitalization subsequent to last dose of study drug that would qualify as an SAE. 3. Based on FDA feedback, the process for collection and recording of AEs was clarified to indicate that additional information would be collected for non-serious psychiatric AEs that led to discontinuation from the study, as well as all serious psychiatric AEs during the study.

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

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