Clinical Trials Logo
  1. Home
  2. Bipolar I Disorder
  3. NCT03257865

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

Bipolar I Disorder Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind Trial of Brexpiprazole Versus Placebo for the Acute Treatment Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder

Clinical Trial Summary

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.

Clinical Trial Description

A multicenter, randomized, double-blind trial of brexpiprazole versus placebo for the acute treatment of manic episodes, with or without mixed features, associated with bipolar I disorder. This study also demonstrated the safety and tolerability of brexpiprazole in the study population of males and females aged 18 to 65 years (inclusive, at time of consent). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03257865
Study type Interventional
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact
Status Completed
Phase Phase 3
Start date September 19, 2017
Completion date January 22, 2019
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03641300 - Efficacy of Convulsive Therapies for Bipolar Depression N/A
Withdrawn NCT01495156 - Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania Phase 4
Completed NCT00982020 - Study in Adolescents With Schizophrenia or Bipolar Disorder Phase 4
Completed NCT00746343 - Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study N/A
Completed NCT00177463 - L-Carnosine for Bipolar I Disorder N/A
Completed NCT03259555 - A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder Phase 3
Completed NCT04127058 - Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia Phase 1
Recruiting NCT05977023 - NMDA Receptor Modulation for the Treatment of Bipolar I Disorder Phase 2
Recruiting NCT05340686 - Braining- Aerobic Physical Activity as Add on Treatment in Bipolar Depression N/A
Completed NCT03287869 - A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder. Phase 3
Enrolling by invitation NCT04987229 - Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects Phase 3
Completed NCT00761761 - Sensoril(Ashwaganhda)for Bipolar Disorder Phase 3
Completed NCT00232414 - A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder Phase 3
Completed NCT03292848 - Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders Phase 1
Active, not recruiting NCT04561622 - Emotional Proactive Processing in Bipolar Disorder
Recruiting NCT03943537 - Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders Phase 2
Completed NCT03334721 - Gabapentin for Bipolar & Cannabis Use Disorders Phase 2
Active, not recruiting NCT05658510 - Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) Phase 3
Completed NCT00958633 - Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder. Phase 3
Completed NCT00177164 - Risperdal Consta for Bipolar Disorder Phase 3