Phase 3 Bipolar Disorder Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been officially diagnosed with Bipolar I Disorder (confirmed using a specific structured interview tool used with children and adolescents).
- Your current depressive episode (period of low mood) has been going on for more than 2 weeks but less than 12 months.
- You have had at least one manic episode (a period of unusually high or irritable mood) at some point in your life.
- Your depression symptoms score at or above a certain level on a standard rating scale at two separate visits (confirm with trial site).
- Your manic symptoms score at or below a certain level on a standard rating scale at two separate visits, meaning mania is not currently severe (confirm with trial site).
- Your overall illness is rated as at least "moderately ill" by a clinician at two separate visits.
Who may not be able to join:
- You have a diagnosis of schizophrenia, schizoaffective disorder, PTSD, antisocial personality disorder, borderline personality disorder, or certain other mental health conditions.
- You have had a diagnosis of a substance use disorder (not including caffeine or tobacco) within the 3 months before the first screening visit.
- You have a history of a serious reaction called serotonin syndrome or neuroleptic malignant syndrome (confirm with trial site).
- You have had four or more mood episodes within the 12 months before the first visit.
- You have a diagnosis of intellectual disability (IQ below 70), autism spectrum disorder, or a chromosomal condition that affects development.
- You have a history of seizures, unless they were only fever-related seizures in childhood.
- You have had a significant head injury, a brain tumour, or another condition that increases the risk of seizures.
- You currently need to take certain medications that affect how the body processes drugs (called CYP3A4 inhibitors or inducers — confirm with trial site).
- You currently need to take any psychiatric medication or other medication, supplement, or herbal product that affects the mind or mood.
- You have received a long-acting injectable antipsychotic medication within a recent period before screening (confirm with trial site).
- You have taken a medication called clozapine at a dose of 50 mg per day or more within the past 2 years.
- You have a history of or currently have any eye condition, such as glaucoma, cataracts, retinal detachment, or eye surgery or trauma — except for simple vision/refractive problems like short-sightedness.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: ABBVIE INC., AbbVie
Phone: 844-663-3742
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Number of Participants with Adverse Events; Abnormal Change from Baseline in Vital Signs; Number of Participants with Incidence of Abnormal Clinical Laboratory Test Results; Change in Electrocardiogram (ECG); Change From Baseline in Simpson-Angus Scale (SAS); Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS); Change From Baseline in Barnes Akathisia Rating Scale (BARS); Change From Baseline in Abnormal Involuntary Movement Scale (AIMS); Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.