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

Recruiting in Palo Alto (17 mi)

+47 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Matthew Leoni, M.D.

Principal Investigator

Otsuka Pharmaceutical Development & Commercialization, Inc.

Eligibility Criteria

Inclusion Criteria

Male or female participants, ages 18 to 65 years, inclusive, at the time of informed consent.

Participants willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.

Participants with a Diagnostic & Statistical Manual on Mental Disorders, 5th Edition (DSM-5) diagnosis of bipolar I disorder displaying an acute manic episode with or without mixed features requiring hospitalization. Diagnosis confirmed by the MINI International Neuropsychiatric Interview and a history of at least 1 previous manic episode with or without mixed features with manic symptoms of sufficient severity to require one of the following interventions: hospitalization or treatment with a mood stabilizer, or treatment with an antipsychotic agent. "Require" was defined as an intervention that occurred rather than one that was recommended.

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Treatment Details

Interventions

Brexpiprazole (Atypical Antipsychotic)
Placebo (Other)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BrexpiprazoleExperimental Treatment1 Intervention

Participants received a starting dose of 2 milligrams (mg)/day brexpiprazole from Days 1 to 3, 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.

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo was administered in the same way as brexpiprazole to maintain the blind.

Brexpiprazole is already approved in Canada, Japan, Brazil for the following indications: