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SEP-363856 75mg for Schizophrenia

Phase 3
Waitlist Available
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 6
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new drug called SEP-363856 in people aged 13-65 with schizophrenia. The goal is to see if the drug can reduce the severity of their symptoms. Participants will receive the drug over a period of several weeks.

Eligible Conditions
  • Schizophrenia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (Week 6)
Secondary study objectives
Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (Week 6)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: SEP-363856 75mgExperimental Treatment1 Intervention
SEP-363856 75mg dosed once daily
Group II: SEP-363856 50mgExperimental Treatment1 Intervention
SEP-363856 50mg dosed once daily
Group III: PlaceboPlacebo Group1 Intervention
Placebo dosed once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SEP-363856 50mg
2019
Completed Phase 3
~470
SEP-363856 75mg
2019
Completed Phase 3
~930

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
265 Previous Clinical Trials
170,061 Total Patients Enrolled
81 Trials studying Schizophrenia
21,432 Patients Enrolled for Schizophrenia
SunovionLead Sponsor
189 Previous Clinical Trials
48,910 Total Patients Enrolled
45 Trials studying Schizophrenia
8,868 Patients Enrolled for Schizophrenia
Sumitomo Pharma America, Inc.Lead Sponsor
241 Previous Clinical Trials
51,422 Total Patients Enrolled
45 Trials studying Schizophrenia
8,868 Patients Enrolled for Schizophrenia
~75 spots leftby Nov 2025
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