Bipolar Disorder Type I With Mania or Mania With Mixed Features

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Review clinical trials related to Bipolar Disorder Type I With Mania or Mania With Mixed Features. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.

Participants needed: 274
Trial details
Phase: Phase 3Age: 18-65Biological sex: AllType: InterventionalSponsor: Bristol-Myers SquibbUpdated: Aug 18, 2026Locations: 85
Eligibility criteria

Participants must have a primary diagnosis of Bipolar-I disorder established by... [+5]

Participants must not have any primary Diagnostic and Statistical Manual of Ment... [+5]