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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

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.

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)

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
264 Previous Clinical Trials
169,617 Total Patients Enrolled
81 Trials studying Schizophrenia
21,421 Patients Enrolled for Schizophrenia
SunovionLead Sponsor
191 Previous Clinical Trials
50,233 Total Patients Enrolled
45 Trials studying Schizophrenia
8,857 Patients Enrolled for Schizophrenia
Sumitomo Pharma America, Inc.Lead Sponsor
242 Previous Clinical Trials
52,673 Total Patients Enrolled
45 Trials studying Schizophrenia
8,857 Patients Enrolled for Schizophrenia
~77 spots leftby Sep 2025
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