NCT03543410

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 344 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Depressive Episode
• Bipolar 1 Depression

Interventions

Type	Name	Description
DRUG	SEP-4199 200 mg	SEP-4199 200 mg/day (supplied in two 100mg tablets)
DRUG	SEP-4199 400 mg	SEP-4199 400 mg/day (supplied in two 200mg tablets
DRUG	Placebo	Placebo (supplied in two tablets/day)

Timeline

• Start date: 2018-06-26
• Primary completion: 2020-04-23
• Completion: 2020-04-23
• First posted: 2018-06-01
• Last updated: 2023-05-18
• Results posted: 2023-05-18

Locations

87 sites across 8 countries: United States, Bulgaria, Japan, Poland, Russia, Serbia, Slovakia, Ukraine

Regulatory

• FDA-regulated drug study