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

Phase 3

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Brexpiprazole	Brexpiprazole	Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4.

Primary Outcome Measures

Name	Time	Method
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) by Severity	From Day 1 (after dosing) through 29 weeks (26 weeks treatment, 3 weeks safety follow-up)	An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs severity were graded on a 3-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, and 3 = severe; inability to work or perform normal daily activity.

Secondary Outcome Measures

Name	Time	Method

Locations (71): Woodland International Research Group
🇺🇸
Little Rock, Arkansas, United States
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
🇺🇸
Torrance, 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
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Woodland International Research Group
🇺🇸Little Rock, Arkansas, United States