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

Schizophrenia Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02969382
Study type Interventional
Source Sunovion
Contact
Status Completed
Phase Phase 2
Start date December 5, 2016
Completion date July 31, 2018
View Details
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