Phase 3 Bipolar Disorder Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who previously took part in one of the related double-blind studies (CN0120036, CN0120037, or CN0120046) and completed the full treatment period of that study.
- People who did not take part in the earlier studies but have a confirmed primary diagnosis of Bipolar I disorder, with symptoms of mania or mixed mania, based on a full psychiatric evaluation using standard diagnostic tools (DSM-5-TR and MINI v7.0.2).
- New participants (those not in earlier studies) whose mania severity score on the Young Mania Rating Scale (YMRS) is 14 or higher at both the screening visit and the start of the study.
- New participants whose overall illness severity score on a standard clinical rating scale (CGI-BP) is 3 or higher at both the screening visit and the start of the study.
- New participants who do not need to be hospitalised for their current manic episode.
Who may not be able to join:
- People who previously enrolled in one of the related KarXT studies but did not complete it (i.e., left the study early).
- New participants for whom the investigating doctor has identified a risk of suicidal behaviour, or who have a history of suicidal behaviour based on a standard assessment tool (C-SSRS).
- New participants whose Bipolar I disorder involves rapid cycling, meaning four or more separate mood episodes within a single year.
- New participants who have had another primary mental health diagnosis — such as Bipolar II disorder, major depressive disorder, borderline personality disorder, or a primary psychotic disorder — within the 12 months before screening (mild anxiety disorders may be an exception; confirm with trial site).
- New participants who have had a moderate to severe substance use disorder (other than tobacco) in the 12 months before screening, or whose current drug or alcohol use is detected through testing at screening.
- New participants who have a history of irritable bowel syndrome (with or without constipation) or serious constipation that required treatment within the past 6 months.
- New participants who have a history of, or are considered at high risk for, urinary retention, gastric retention, or untreated narrow-angle glaucoma.
- There are additional eligibility requirements set out in the study protocol that the trial site will assess (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb
Phone: 855-907-3286
Australian sites
0294331546
0408707842
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of participants with treatment emergent adverse events (TEAEs)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.