NCT02969382

A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia

A 4-Week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexibly-dosed, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adult Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the efficacy and safety of an experimental drug (SEP-363856) in acutely psychotic adults with schizophrenia

Detailed description

This is a multicenter, randomized, double-blind, parallel-group, flexibly-dosed, study evaluating the efficacy and safety of SEP-363856 in acutely psychotic adult subjects with schizophrenia using SEP-363856 (50 or 75 mg/day \[ie, once daily\]) versus placebo over a 4-week treatment period. Primary hypoathesis to be tested: H0: μSEP = μPBO versus H1: μSEP ≠ μPBO, where μSEP and μPBO are the mean changes from Baseline at Week 4 in PANSS total score for the SEP-363856 and placebo arms, respectively. Subjects who complete study SEP361-201 may be eligible to enroll in the open-label extension study SEP361-202.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	SEP-363856	One SEP-363856 capsule (50 mg or 75 mg) daily for four weeks
DRUG	Placebo - Cap	One Placebo capsule daily for 4 weeks

Timeline

• Start date: 2016-12-05
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2016-11-21
• Last updated: 2024-07-05
• Results posted: 2021-09-22

Locations

33 sites across 5 countries: United States, Hungary, Romania, Russia, Ukraine