Clin2
NCT06929273Possibly a fitRecruiting

Long-term safety study of KarXT for bipolar I mania

Bipolar Disorder Type I With Mania

Treatments studied

Part of Brain & nervous system clinical trials.

This study tests the long-term safety of KarXT for people with bipolar I disorder who are having a manic or mixed episode. It is for people who either completed a previous KarXT study or are new to the study and have moderate to severe mania symptoms.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
450 people
Ages
18 years to 65 years
Study type
Interventional

Who can take part

  • You have bipolar I disorder with current mania or mixed mania symptoms that are moderate to severe.
  • You are not in immediate need of hospitalization for mania.
  • You do not have rapid cycling (4 or more mood episodes in a year) if you are new to the study.
  • You do not have certain other mental health conditions (like major depression, borderline personality, or bipolar II) within the last year.
  • You do not have a moderate to severe substance use disorder (excluding tobacco) in the past year.
  • You do not have a history of irritable bowel syndrome, severe constipation, or other stomach or bladder problems.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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