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

Completed · Phase 3

Conditions studied: Bipolar I Disorder, Acute Mania

In brief

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.

Key facts

Study ID

NCT03287869

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

381

Starts

2017-10-24

Expected to finish

2019-07-31

Last updated by the study team

2020-08-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Woodland Research Northwest, LLC — Rogers, Arkansas, United States
• Citrials Inc. — Bellflower, California, United States
• Radiant Research — Cerritos, California, United States
• ProScience Research Group — Culver City, California, United States
• Collaborative Neuroscience Network, LLC — Garden Grove, California, United States
• Behavioral Research Specialists, LLC — Glendale, California, United States
• Apostle Clinical Trials — Long Beach, California, United States
• Pacific Research Partners, LLC — Oakland, California, United States
• NRC Research Institute — Orange, California, United States
• Asclepes Research Centers, PC — Panorama City, California, United States
• CI Trials — Riverside, California, United States
• CNRI-San Diego — San Diego, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Sharp Mesa Vista Hospital — San Diego, California, United States
• CI Trials — Santa Ana, California, United States
• Collaborative Neuroscience Network, LLC — Torrance, California, United States
• Shreenath Clinical Service — Yorba Linda, California, United States
• Optimus U Corp — Coral Gables, Florida, United States
• Segal Trials — Fort Lauderdale, Florida, United States
• Galiz Research — Hialeah, Florida, United States
• Research Centers of America, LLC — Hollywood, Florida, United States
• Florida Behavioral Medicine — Largo, Florida, United States
• University of South Florida Board of Trustees — Tampa, Florida, United States
• iResearch Atlanta, LLC — Decatur, Georgia, United States
• Woodland International Research Group — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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