NCT05169710

A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.

A Multi-region, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A clinical trial to study the efficacy and safety of an investigational drug in people with major depressive episodes associated with with Bipolar I disorder (bipolar I depression) Participants in the study will either receive the drug being studied or a placebo. The study will be conducted in approximately 90 sites in North America, Europe, Latin America and Japan. It will be have both male and female participants ages 18-65. Participation in the study will be approximately 10 weeks.

Detailed description

This study is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of treatment with SEP-4199 CR at fixed doses of 200 mg/day or 400 mg/day compared with placebo for the treatment of major depressive episode associated with bipolar I disorder (bipolar I depression). The study is projected to randomize approximately 522 subjects inNorth America, Japan, Europe and Latin America, to SEP-4199 CR 200 mg/day, SEP-4199 CR 400 mg/day, and placebo treatment groups in a 1:1:1 ratio

Conditions

• Depressive Episodes, Bipolar I Depression

Interventions

Type	Name	Description
DRUG	SEP-4199 CR 200 mg	SEP-4199 CR 200 mg Tablet (supplied in one 200mg tablet and one placebo tablet)
DRUG	SEP-4199 CR 400 mg	SEP-4199 CR 400 mg tablet (supplied in two 200mg tablets)
DRUG	Placebo	Placebo tablet (supplied in two tablets)

Timeline

• Start date: 2021-12-21
• Primary completion: 2023-10-18
• Completion: 2023-10-18
• First posted: 2021-12-27
• Last updated: 2024-10-03
• Results posted: 2024-09-19

Locations

89 sites across 6 countries: United States, Bulgaria, Canada, Japan, Romania, Slovakia

Regulatory

• FDA-regulated drug study