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

  • STATUS
    Not Recruiting
  • participants needed
    339
  • sponsor
    Sunovion
Updated on 2 December 2021
Investigator
CNS Medical Director
Primary Contact
Hatakeyama Clinic (0.0 mi away) Contact
+102 other location

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

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).

Details
Condition Endogenous depression, Bipolar 1 Depression
Treatment Placebo, SEP-4199 200 mg, SEP-4199 400 mg
Clinical Study IdentifierNCT03543410
SponsorSunovion
Last Modified on2 December 2021

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