Adults 18 to 40, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Incidence of Overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to DiscontinuationPrimary· From first dose of study drug to last study visit (27 weeks)
Number of Participants with overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation
Overall Adverse Events (AEs)
Group
Value
95% CI
SEP-363856
88
Serious Adverse Events (SAEs)
Group
Value
95% CI
SEP-363856
15
Adverse Events leading to discontinuation from study
Group
Value
95% CI
SEP-363856
18
Adverse Events leading to discontinuation of study drug
Group
Value
95% CI
SEP-363856
18
Frequency of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)Secondary· Overall post Open-label Baseline treatment period (26 weeks)
Number of participants with suicidal ideation (SI) and suicidal behavior (SB) using the Columbia - Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.
Any suicidal ideation
Group
Value
95% CI
SEP-363856
3
Any suicidal behavior
Group
Value
95% CI
SEP-363856
1
Any suicidality
Group
Value
95% CI
SEP-363856
3
Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)Secondary· Overall post Open-label Baseline treatment period (26 weeks)
The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.
SI: Wish to be dead
Group
Value
95% CI
SEP-363856
2
SI: Non-specific active suicidal thoughts
Group
Value
95% CI
SEP-363856
2
SI: Any methods (not plan) without intent to act
Group
Value
95% CI
SEP-363856
0
SI: Some intent to act, without specific plan
Group
Value
95% CI
SEP-363856
0
SI: Specific plan and intent
Group
Value
95% CI
SEP-363856
0
SB: Preparatory acts or behavior
Group
Value
95% CI
SEP-363856
0
SB: Aborted attempt
Group
Value
95% CI
SEP-363856
1
SB: Interrupted attempt
Group
Value
95% CI
SEP-363856
0
Time to Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856Secondary· From the time of clinical response to relapse or censor (one day after the last study drug dose)
Relapse is defined as the earliest occurrence of any of the following: - An increase in PANSS total score by ≥ 30% from the PANSS total score at clinical response and a CGI-S score ≥ 3; - Re-hospitalization for worsening of psychosis; - Emergence of suicidality, homicidality, and/or risk of harm to self or others.
Group
Value
95% CI
PBO-SEP
NA
NA – NA
SEP-SEP
NA
NA – NA
Rate of Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856Secondary· From the time of clinical response to relapse or censor (one day after the last study drug dose)
Relapse is defined as the earliest occurrence of any of the following: - An increase in PANSS total score by ≥ 30% from the PANSS total score at clinical response and a CGI-S score ≥ 3; - Re-hospitalization for worsening of psychosis; - Emergence of suicidality, homicidality, and/or risk of harm to self or others.
Group
Value
95% CI
PBO-SEP
12
SEP-SEP
11
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)Secondary· Double-blind Baseline (DB BLN), Open-label Baseline (OL BLN), Week 26 (Wk 26)
PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). 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. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.
Total Score: DB BLN Observed
Group
Value
95% CI
SEP-363856
101.5
± 7.99
Total Score: OL BLN Observed
Group
Value
95% CI
SEP-363856
83.1
± 15.03
Total Score: Wk 26 Observed
Group
Value
95% CI
SEP-363856
59.3
± 12.45
Total Score: Chg from DB BLN at Wk 26
Group
Value
95% CI
SEP-363856
-41.8
± 13.98
Total Score: Chg from OL BLN at Wk 26
Group
Value
95% CI
SEP-363856
-22.6
± 15.48
Positive SS: DB BLN Observed
Group
Value
95% CI
SEP-363856
25.7
± 3.22
Positive SS: OL BLN Observed
Group
Value
95% CI
SEP-363856
19.8
± 4.96
Positive SS: Wk 26 Observed
Group
Value
95% CI
SEP-363856
12.2
± 3.72
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Clinical Global Impression - Severity (CGI-S) ScoreSecondary· Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26
The CGI-S is 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 is associated with greater illness severity.
CGI-S Score: DB Baseline Observed
Group
Value
95% CI
SEP-363856
5.0
± 0.42
CGI-S Score: OL Baseline Observed
Group
Value
95% CI
SEP-363856
4.0
± 0.84
CGI-S Score: Week 26 Observed
Group
Value
95% CI
SEP-363856
3.0
± 0.74
CGI-S Score: Change from DB Baseline at Week 26
Group
Value
95% CI
SEP-363856
-2.0
± 0.82
CGI-S Score: Change from OL Baseline at Week 26
Group
Value
95% CI
SEP-363856
-1.0
± 0.91
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Brief Negative Symptom Scale (BNSS) Total ScoreSecondary· Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26
The BNSS is a rating scale to measure the current level of severity of negative symptoms in schizophrenia and schizoaffective disorder. The measure is comprised of 13 individual items organized in 6 subscales. The 13 individual items provide a composite total score (ranging from 0 to 78). Each of the items are scored on a Likert-type 7-point scale from 0 - 6, where values of 0 indicates symptom is absent and a value of 6 means the symptom is a severe form.
Total Score: DB Baseline Observed
Group
Value
95% CI
SEP-363856
38.4
± 11.94
Total Score: OL Baseline Observed
Group
Value
95% CI
SEP-363856
33.0
± 11.41
Total Score: Week 26 Observed
Group
Value
95% CI
SEP-363856
22.5
± 11.83
Total Score: Change from DB Baseline at Week 26
Group
Value
95% CI
SEP-363856
-16.8
± 12.42
Total Score: Change from OL Baseline at Week 26
Group
Value
95% CI
SEP-363856
-11.3
± 9.69
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) Total ScoreSecondary· Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26
The MADRS is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts. Each item is scored in a range of 0 to 6 points, with higher scores indicating increased depressive symptoms.
Total score will be equal to the sum of the 10 items (range between 0 and 60).
Total Score: DB Baseline Observed
Group
Value
95% CI
SEP-363856
12.6
± 7.25
Total Score: OL Baseline Observed
Group
Value
95% CI
SEP-363856
9.2
± 6.33
Total Score: Week 26 Observed
Group
Value
95% CI
SEP-363856
4.4
± 4.72
Total Score: Change from DB Baseline at Week 26
Group
Value
95% CI
SEP-363856
-8.1
± 6.44
Total Score: Change from OL Baseline at Week 26
Group
Value
95% CI
SEP-363856
-4.5
± 5.28
Proportion of Subjects Who Achieved a Response, Defined as a 20% or Greater Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score From Double-blind Baseline of Study SEP361-201Secondary· Week 26
PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). 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. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.
Group
Value
95% CI
PBO-SEP
52
SEP-SEP
49
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug to last study visit (27 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc.
Last refreshed: 5 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02970929.