Phase 2 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:
- Your Body Mass Index (BMI) — a measure of body weight relative to height — must be between 18.0 and 40.0.
- You must have been diagnosed with bipolar I or II disorder (without psychotic features) according to standard psychiatric guidelines, and currently be going through a depressive episode that has lasted at least 4 weeks but no longer than 12 months.
- Your physical exam, blood/lab tests, vital signs, and heart tracing (ECG) results must be normal, or any unusual results must be considered not medically significant by the study doctor.
- You must have no history of a psychiatric hospital stay (including intensive outpatient programs) in the past 3 months.
- You must have no history of schizophrenia, other psychotic disorders, dissociative disorders, or memory/cognitive disorders at any point in your life.
- You must have no history of moderate or severe drug or alcohol misuse (other than nicotine) in the past 6 months.
- If you have other stable mental health conditions (such as PTSD or OCD), you may still qualify, as long as those conditions have not required any medication that is not allowed in this trial within the past 12 months.
Who may not be able to join:
- People whose manic symptoms score above 12 on a standard rating scale (called the Young Mania Rating Scale) at the start of the study.
- People who have had an allergic reaction or strong sensitivity to the study drug or similar medications.
- People with a serious or unstable physical health condition that could affect the study or put them at risk — this includes certain heart, kidney, liver, lung, blood, hormonal, digestive, or neurological conditions, or a history of most types of cancer (confirm with trial site if your condition has been stable for over a year, as exceptions may apply).
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 Experiencing Adverse Events; Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements; Number of Participants with Change from Baseline in Electrocardiogram (ECG); Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed; Change From Baseline in Simpson-Angus Scale (SAS); Change From Baseline in Abnormal Involuntary Movement Scale (AIMS); Change From Baseline in Barnes Akathisia Rating Scale (BARS); Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS); Change From Basel...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.