NCT03259555

A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder

A Multicenter, Randomized, Double-blind Trial of Brexpiprazole Versus Placebo for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the efficacy of brexpiprazole for the acute treatment of manic episodes, with or without mixed features, in participants with a diagnosis of bipolar I disorder.

Detailed description

A multicenter, randomized, double-blind trial of brexpiprazole versus placebo for the acute treatment of manic episodes, with or without mixed features, associated with bipolar I disorder. This study also demonstrated the safety and tolerability of brexpiprazole in the study population of males and females aged 18 to 65 years (inclusive, at time of consent).

Conditions

• Bipolar I Disorder
• Manic Episode

Interventions

Type	Name	Description
DRUG	Brexpiprazole	Brexpiprazole was administered orally with flexible dosing from 2 to 4 mg/day; titrated to a maximum of 4 mg/day for 3 weeks.
DRUG	Placebo	Administered orally daily for 3 weeks.

Timeline

• Start date: 2017-09-14
• Primary completion: 2019-01-02
• Completion: 2019-01-02
• First posted: 2017-08-23
• Last updated: 2020-02-10
• Results posted: 2020-02-10

Locations

48 sites across 4 countries: United States, Bulgaria, Poland, Serbia

Regulatory

• FDA-regulated drug study