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 have been formally diagnosed with Bipolar I disorder through a thorough psychiatric assessment.
- People who are currently experiencing an acute episode of mania or mania with mixed features that has lasted 3 weeks or less.
- People whose symptoms are severe enough to require a hospital stay.
- People who have stopped taking all psychiatric medications within the 14 days before starting the study drug.
- People whose mania symptoms score at or above a certain level (≥20) on a standard rating scale called the Young Mania Rating Scale, measured at two separate points before the trial begins.
- People whose overall illness severity scores at or above a certain level (≥4) on a standard clinical rating tool called the CGI-BP, measured at two separate points before the trial begins.
Who may not be able to join:
- People who have been diagnosed with certain other mental health conditions in the past 12 months — including Bipolar II disorder, borderline personality disorder, major depressive disorder, or a primary psychotic disorder — or who have experienced a Bipolar I depressive episode in the past 3 months. Mild anxiety disorders are an exception to this rule.
- People whose Bipolar I disorder involves rapid cycling, meaning four or more distinct mood episodes within one year.
- People who have had a moderate to severe substance use disorder (other than tobacco) in the past 12 months, or whose urine or alcohol testing shows current substance use.
- People assessed as being at risk of suicidal behaviour at the time of screening or the baseline visit, based on clinical judgement and a standardised suicide risk scale.
- People who have cirrhosis, liver cancer, or clinically significant liver disease based on liver function test results.
- There are additional criteria not listed here 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
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
Primary endpoints
Change from baseline in Young Mania Rating Scale (YMRS) score
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.