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A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression

Depressive Episode Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of SEP-4199 for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)

Clinical Trial Summary

A clinical study to test the effectiveness of an investigational drug to treat people that have major depressive episodes when they have Bipolar 1 Depression

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study designed to evaluate the efficacy, safety, and tolerability of treatment with SEP-4199 monotherapy given as 200 mg/day or 400 mg/day compared with placebo for the treatment of major depressive episodes associated with bipolar I disorder (bipolar I depression). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03543410
Study type Interventional
Source Sunovion
Contact
Status Completed
Phase Phase 2
Start date June 26, 2018
Completion date April 23, 2020
View Details
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