NCT03287869

A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.

A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Bipolar I Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the safety and evaluate the safety and tolerability of open-label brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult subjects with bipolar I disorder. All participants received a starting dose of brexpiprazole.

Detailed description

While the availability of atypical antipsychotics had increased the therapeutic options available, there remains a need for safer and more effective therapies in the treatment of manic and depressive episodes of bipolar I disorder. Brexpiprazole's specific receptor activity profile likely correlates with its established efficacy in schizophrenia and major depressive disorder, and may prove to be an effective target for the treatment of acute mania of bipolar I disorder.

Conditions

• Bipolar I Disorder
• Acute Mania

Interventions

Type	Name	Description
DRUG	Brexpiprazole	Brexpiprazole tablets

Timeline

• Start date: 2017-10-24
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2017-09-19
• Last updated: 2020-08-17
• Results posted: 2020-08-17

Locations

73 sites across 6 countries: United States, Bulgaria, Croatia, Poland, Serbia, Ukraine

Regulatory

• FDA-regulated drug study