In Patient Clinical Trial for the Treatment of Manic Episodes in Bipolar-I Disorder
- Study IRB#:2000040866
- Last Updated:04/09/2026
The study drug KarXT is a new medication that combines two medicines into one treatment. It is designed to help treat psychiatric conditions, including bipolar mania. One part of the medication works in the brain to help improve symptoms, while the other part helps reduce unwanted side effects in the body. The second component mainly stays outside the brain, so it can block certain side effects without affecting how well the treatment works. This approach may offer a new way to treat bipolar mania, since many current medications work in similar ways and often have similar side effects.
- Age18 years - 65 years
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Kimberlee Forselius-Bielen
- Phone Number: 1-203-974-7540
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility Criteria
- Participant must be 18 to 65 years of age
- Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria
- The individual is experiencing an acute episode or relapse of mania or mania with mixed features (less than or equal to 3 weeks).
- The individual requires hospitalization for the acute exacerbation or relapse of mania.
- All psychotropic medications are washed out in no more than 14 days prior to the first dose of the study drug.
- Young Mania Rating Scale (YMRS) score of greater than or equal to 20 at time of screening.
- Clinical Global Impressions-Bipolar (CGI-BP) greater than or equal to 4 at time of screening.
