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:

• Adults aged 18 or older, whether currently in hospital or being treated as an outpatient.
• People who are able and willing to sign a consent form agreeing to take part (a legal guardian may co-sign if needed).
• Women who could become pregnant must use effective contraception throughout the trial and must have a negative pregnancy test before the trial begins. Men who will be taking valproic acid as part of the trial must also use effective contraception throughout.
• People who have been diagnosed with bipolar depression (either bipolar disorder type I or type II, currently in a depressive episode), confirmed using a standardised diagnostic interview.
• People whose current treatment is not working well enough — confirmed by a clinician's rating — and whose current treatment was ideally a first-line medication taken for at least 4 weeks at an appropriate dose (other treatments are also accepted).
• People where both the patient and their treating doctor agree that a change in medication is needed.
• People with at least a moderate level of depression symptoms, measured by a score of 20 or higher on a recognised depression rating scale, and whose daily functioning is noticeably affected, measured by a score of 5 or higher on at least one area of a standard functioning scale.

Who may not be able to join:

• People who are pregnant or breastfeeding.
• People who are known to have an intolerance to quetiapine and to all the other medication options available in the trial.
• People who have a medical reason why they cannot safely take quetiapine or any of the other medication options in the trial, including based on blood test results, heart trace (ECG), or physical examination findings.
• People who have taken part in another clinical trial involving an experimental drug or treatment within the past 30 days.
• People who have another significant illness or condition that, in the investigator's opinion, could put them at risk or affect the trial results.
• People who are experiencing active thoughts of suicide with some intent to act, or with a specific plan and intent, where the treating clinician judges that it would not be safe for them to participate.
• People who currently meet the criteria for a serious substance use disorder — severe alcohol or cannabis use disorder is not permitted (mild or moderate alcohol or cannabis use disorder and nicotine dependence are allowed).
• People who have been admitted to an institution under a legal or government order (confirm with trial site).
• People with a high score on a mania rating scale (score of 12 or above), indicating significant manic or mixed symptoms.
• People who have a close dependent relationship with the trial sponsor, investigator, or trial site.
• People with existing severe liver damage, as identified by blood tests at the start of the trial.
• People with a history of mania or hypomania triggered by antidepressants, or a recent history of rapidly alternating mood episodes.

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