Phase 2 Bipolar Disorder Trial, Recruiting

Written by an AI model from the 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 are a man or woman between 18 and 65 years old (inclusive)
• You have been diagnosed with Bipolar Disorder Type I or Type II (according to DSM-IV criteria)
• You are able to read and sign a consent form to participate in the study
• You have been taking an approved medication for bipolar mania at an adequate dose for at least two weeks before joining
• You are willing to keep your medications the same throughout the study
• You are currently going through a major depressive episode, confirmed by a standard assessment tool with a score above 18 at the start of the study
• You are not currently experiencing a hypomanic or manic episode

Who may not be able to join:

• You have certain other mental health diagnoses, including Bipolar NOS, Cyclothymia, Schizoaffective Disorder, Schizophrenia, OCD, severe borderline or antisocial personality disorder, delusional disorder, other psychotic disorders, organic mental disorders, or active substance or alcohol use disorder within the past 3 months, or acute grief/bereavement
• Your primary diagnosis or main treatment focus is an anxiety disorder
• You have psychotic features (such as hallucinations or delusions) alongside your mood symptoms
• You are pregnant, breastfeeding, or able to become pregnant and not using a medically accepted form of contraception
• You are considered to be at serious risk of suicide or harming others
• You have an unstable or poorly controlled physical health condition, such as epilepsy, unstable angina, untreated hormonal disorders, recent ulcers, or significant digestive issues
• You have a liver or gallbladder disease or condition that could be made worse by the study medication (bezafibrate)
• You have a thyroid condition that is not well controlled, or have not been stable on thyroid medication for at least one month before the study starts
• You have already tried two or more treatments (medications or approved devices) for bipolar depression during your current depressive episode without success
• You are currently taking a fibrate medication, or have ever had a severe allergic reaction or intolerance to fibrates
• You have a history of not following treatment plans, or the study doctor believes you are unlikely to stick to the treatment
• You have a history of stroke or disease affecting the blood vessels in the brain
• You have Type 1 or Type 2 diabetes and are being treated with Pioglitazone or a similar type of medication (PPAR agonist)
• You are currently taking MAO inhibitors, statins, or blood-thinning medications such as warfarin

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