Phase 3 Bipolar Disorder Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been formally diagnosed with Bipolar I disorder through a full psychiatric evaluation
• People who are currently experiencing an acute manic episode or a manic episode with mixed features that has lasted 3 weeks or less
• People whose condition requires them to be admitted to hospital for their current manic episode
• People who have stopped taking all psychiatric medications within 14 days before starting the study drug
• People who score 20 or higher on a standard mania rating scale (called the YMRS) at both the screening and baseline assessments
• People who score 4 or higher on a standard clinical severity scale for bipolar disorder (called the CGI-BP) at both the screening and baseline assessments

Who may not be able to join:

• People who have been diagnosed with certain other mental health conditions in the 12 months before screening — including Bipolar II disorder, borderline personality disorder, major depressive disorder, or a primary psychotic disorder (mild anxiety disorders are generally an exception; confirm with trial site)
• People whose Bipolar I diagnosis involves a pattern of rapid cycling, meaning 4 or more distinct mood episodes in a single year
• People who have had a moderate to severe substance use disorder (other than tobacco) in the 12 months before screening, or who show current substance or alcohol use on testing
• People considered to be at risk of suicidal behaviour at the time of screening or the baseline visit, based on clinical assessment and a standardised safety scale (the C-SSRS)
• People who have a history of irritable bowel syndrome or serious constipation that required treatment within the last 6 months
• People who have a history of, or are considered at high risk for, difficulty urinating, stomach or bowel retention, or untreated narrow-angle glaucoma
• Additional criteria set by the trial protocol may also apply (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.