SEP-363856 for Schizophrenia

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants with Schizophrenia

Research Team

Eligibility Criteria

This trial is for adults aged 18-65 with schizophrenia, who are experiencing a recent worsening of symptoms and have responded well to antipsychotic treatment in the past year. They must be hospitalized or require hospitalization due to acute symptoms but haven't been hospitalized for more than two weeks at screening time.

Inclusion Criteria

My mental health has recently worsened significantly.

I responded well to antipsychotic treatment in the past year.

I am between 18 and 65 years old.

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Exclusion Criteria

Participant has had a decrease of ≥ 20% on the PANSS total score between screening and baseline

Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia

Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug

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Treatment Details

Interventions

Placebo (Other)
SEP-363856 (Other)

Trial OverviewThe study tests SEP-363856 against a placebo in people with acute schizophrenia. It's a phase 3 trial, meaning it's advanced in testing the drug's effectiveness and safety. Participants will be randomly assigned to either the drug or placebo without knowing which one they receive.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: SEP-363856 75 mgExperimental Treatment1 Intervention

SEP-363856 75 mg/day

Group II: SEP-363856 100 mgExperimental Treatment1 Intervention

SEP-363856 100 mg/day

Group III: PlaceboPlacebo Group1 Intervention

Placebo