Clinical trials: Bipolar-I Disorder With Mania or Mania With Mixed Features, open to volunteers
Bipolar Disorder Type I With Mania or Mania With Mixed Features
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.
- Trial name
- NCT06951711
- Testing
- KarXT
- Where
- 85 sites in United States, China and 9 more
- Volunteers
- 274 people
- Sponsor
- Bristol-Myers Squibb
Mania, Bipolar Disorder
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.
- Trial name
- NCT07140913
- Testing
- Xanomeline/Trospium Chloride
- Where
- 109 sites in United States, Argentina and 11 more
- Volunteers
- 424 people
- Sponsor
- Bristol-Myers Squibb
Bipolar Disorder Type I With Mania
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the…
- Trial name
- NCT06929273
- Testing
- KarXT, Lithium, Valproate
- Where
- 184 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Bristol-Myers Squibb
Bipolar I Disorder, Mania
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or…
- Trial name
- NCT07288320
- Testing
- NBI-1117568
- Where
- 11 sites in United States
- Volunteers
- 150 people
- Sponsor
- Neurocrine Biosciences
Bipolar-I Disorder With Mania or Mania With Mixed Features
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
- Trial name
- BALSAM-1 (NCT06951698)
- Testing
- KarXT
- Where
- 74 sites in United States, Argentina and 7 more
- Volunteers
- 274 people
- Sponsor
- Bristol-Myers Squibb