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COMPLETEDPhase 3NCT03287869

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

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...

Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.•44 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

H. Lundbeck A/S

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.

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Participants remaining in hospital at the Day 21 visit of trial 331-201-00080 or 331-201-00081 were permitted to enroll in the 331-201-00083 trial at the week 3 visit of the double-blind trial if they were planned to be discharged from the hospital before the week 1 visit of trial 331-201-0083. Participants not discharged by the week 1 visit of trial 331-201-0083 were withdrawn.
•Participants who, in the opinion of the investigator, could potentially benefit from administration of oral brexpiprazole for the treatment of bipolar I disorder and who completed 3 weeks of post-randomization treatment in Trial 331-201-00080 \& Trial 331-201-00081.

Exclusion Criteria

•Participants with a major protocol violation during the course of their participation in the double-blind phase 3 trials (331-201-00080 or 331-201-00081).

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 17, 2020Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment381

Start dateOct 2017

Last updatedAug 17, 2020

Condition

Bipolar I Disorder Acute Mania

Locations shown

Woodland International Research Group

Little Rock, Arkansas

Woodland Research Northwest, LLC

Rogers, Arkansas

Citrials Inc.

Bellflower, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2020Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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