Phase 4 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:

• You have been diagnosed with bipolar disorder (type 1 or type 2) and are currently going through a depressive episode, as defined by standard diagnostic guidelines (DSM-5).
• Your depression is scored as at least 21 out of 50 on a self-reported depression questionnaire called the Major Depression Inventory (MDI).
• You have not started or increased the dose of any psychiatric medication (except certain sleep aids or anti-anxiety medicines) in the two weeks before joining.
• You have not started any new formal talking therapy (other than general education about your condition) in the four weeks before joining.
• You are between 18 and 64 years old at the time of joining the trial.
• Your current depressive episode has been going on for between 4 and 52 weeks, as assessed by the doctor running the trial.
• The trial doctor is genuinely uncertain which of the two study medications — cariprazine or lithium — would be better for you specifically.
• If you are a woman who could become pregnant, you must have a negative pregnancy test and be using a reliable form of contraception.
• You are willing and able to sign a consent form agreeing to take part.

Who may not be able to join:

• You have already been treated for your current depressive episode for more than 14 days with either lithium or cariprazine.
• You have had electroconvulsive therapy (ECT — a treatment using electrical stimulation) during your current depressive episode.
• You have scored above 6 on a scale used to measure symptoms of mania (MAS scale).
• You have a diagnosis of dementia.
• The trial doctor believes there is a high risk that you may not be able to stick to the treatment plan.
• You are not able to understand the Danish language, as judged by the trial doctor.
• You are currently under any form of involuntary psychiatric treatment, such as forced hospital admission, or have been ordered into forensic psychiatric care by a court.
• You are currently experiencing significant delusions, hallucinations, or other psychotic symptoms, as assessed by the trial doctor.
• You have expressed certain levels of suicidal thoughts or intentions, as measured by a standard assessment tool (C-SSRS), or as judged by the trial doctor.
• You have certain serious health conditions — such as cancer, kidney failure, epilepsy, or a deep brain stimulation device — that could affect the trial results or your safety (confirm with trial site).
• You currently have a harmful dependency on alcohol or drugs, as defined by standard diagnostic guidelines (DSM-5).
• You have a known allergy to any ingredient in either of the study medications.

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