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NCT00001483
NCT00001483
Who may be able to join
Who might be able to join this trial:
- You have been diagnosed with Bipolar I disorder, Bipolar II disorder, Bipolar disorder not otherwise specified, or schizoaffective disorder (bipolar type).
- You are able to understand the purpose of the study and are willing and able to give your informed consent to participate.
- You are willing to complete a full psychiatric interview, physical and neurological exams, and various lab tests including blood tests, urine tests, an EKG (heart trace), and tests for HIV, hepatitis B, and drug use (confirm with trial site for full list).
- You are at least 18 years old.
- You are currently experiencing depression that is severe enough to score at a certain level on a standard depression rating scale, or your doctor has decided you need antidepressant treatment, and you are already taking at least one mood stabilizer medication.
- Your mood disorder is not being caused by another physical health condition.
- If you are a woman who could become pregnant, you must not currently be pregnant or breastfeeding, and you must be using an accepted form of birth control.
Who may not be able to join:
- You have liver, kidney, blood, or neurological (brain/nerve) disease.
- Your alcohol or drug use is serious enough that you need separate, dedicated treatment for it (such as hospitalization, a day treatment program, or regular counselor visits — not including self-help groups).
- You are taking other medications that would not be safe to use alongside the medications being studied in this trial, such as chemotherapy drugs.
- You have a history of bulimia (an eating disorder involving purging) or a seizure disorder (such as epilepsy).
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.
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Trial details
Status
Completed
Phase
Phase 2
Sponsor
National Institute of Mental Health (NIMH)
Registry
clinicaltrials_gov
Start date
1 June 1995
Where this trial is recruiting
🇺🇸 United States
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.