Study Purpose: This study is testing a medicine called KarXT to see if it helps treat manic episodes in people with Bipolar-I Disorder. Manic episodes are periods when people feel very excited, active, or irritable.
Study Details: The study compares KarXT with a placebo, which is a pill that looks like medicine but doesn’t have any active ingredients. It's a Phase 3 trial, meaning it’s close to being fully tested. The study lasts up to 7 weeks, with 3 weeks spent in the hospital. Participants will stop taking other mental health medicines before starting the study drug.
- Participants stay in the hospital for 3 weeks and need to visit the study site a few times.
- All other mental health medications must be stopped 14 days before starting KarXT.
- Participants must not have serious substance use issues or other mental disorders.
People who join need to have Bipolar-I Disorder with a current manic episode and need to be in the hospital for treatment. They should not have other major mental illnesses or substance problems. The study will help understand if KarXT is safe and effective for treating manic episodes.