clinical trial · NCT07140913
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
Bristol-Myers Squibb·phase3·recruiting·n = 424
ManiaBipolar DisorderXanomeline/Trospium ChloridePlacebo
brief summary
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.
started
Oct 8, 2025
primary completion
Jun 28, 2027
completion
Jun 28, 2027
last updated
Jun 10, 2026
official title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol