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, confirmed through a full psychiatric assessment using standard diagnostic guidelines and a recognised psychiatric interview tool.
• People who are currently experiencing a sudden worsening or relapse of a manic episode (with or without mixed mood features) that started within the last 3 weeks.
• People whose current manic episode is severe enough to require a hospital stay.
• People whose body weight falls within a healthy to moderately overweight range (BMI between 18 and 40).
• People who are already taking a mood-stabilising medication (lithium, valproate, or lamotrigine) at a full therapeutic dose that has remained unchanged for at least two weeks before the screening visit — and, for those taking valproate, who have been on it for at least seven months — but who are still experiencing an active manic episode despite this treatment.
• People whose manic symptoms score at a certain level of severity on a standard rating scale (called the YMRS) at both the screening and baseline appointments, with no major improvement between those two visits.

Who may not be able to join:

• People who have been diagnosed with another primary mental health condition in the past 12 months — including Bipolar I depression (within the past 3 months), Bipolar II disorder, rapid cycling Bipolar I, a first-ever manic episode, a primary psychotic disorder, borderline personality disorder, or major depressive disorder — though mild anxiety disorders may be an exception (confirm with trial site).
• People who have had a moderate to severe substance use disorder (other than tobacco) in the past 12 months, or who show signs of current substance or alcohol use at the time of screening.
• People assessed as being at risk of suicidal behaviour, based on clinical judgement and responses to a standard suicide risk questionnaire, within specified timeframes before or during the screening process.
• People with a history of irritable bowel syndrome or significant constipation requiring treatment within the past 6 months.
• People with a history of, or high risk of, difficulty urinating, stomach emptying problems, or a type of eye condition called narrow-angle glaucoma.
• People with HIV, liver cirrhosis, problems with the bile ducts, liver cancer, or an active viral liver infection.
• People whose liver function blood test results show certain elevated levels at screening, unless a specific harmless liver condition called Gilbert's syndrome explains the result.
• People with any level of liver impairment, whether mild, moderate, or severe.
• Other criteria defined in the study protocol may also apply (confirm with trial site).

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