Omega-3 Fatty Acids in Bipolar Disorder

Inclusion criteria

• Meet DSM-IV criteria for bipolar disorder, type I.
• Have had an episode of mania, hypomania, mixed mania, or major depression within the preceding 12 months, as defined by SCID criteria.
• Able to give informed consent.

Exclusion criteria

• Patients with significant medical co-morbidity, such as active hepatic or renal disease, any type of coagulopathy, lipidoses, dementia, history of significant head injury, active cancer or cancer treatment, or other medical problems which may interfere with the absorption and metabolism of omega-3 fatty acids. In addition, any medical disorder with symptoms (e.g. aphasia, encephalopathy, etc.) which would make it difficult to determine the clinical response to the study drugs.
• Patients with significant psychiatric co-morbidity, such as another currently active Axis 1 or 2 disorder requiring treatment. Patients with other, active mental disorders may have psychiatric symptoms that would make it difficult to assess mood response to the study drugs. For example, a patient with significant anxiety or panic symptoms requiring medication would be excluded, whereas a patient with past or currently very mild anxiety symptoms not requiring active treatment would be eligible.
• Patients receiving Coumadin, or other drugs with strong effects on coagulation will be excluded due to the theoretical increased risk of bleeding on omega-3 fatty acid therapy. Low dose or intermittent NSAIDs will be permitted.
• Patients receiving drugs which affect lipid metabolism, such as HMG CoA inhibitors, high-dose niacin, gemfibrozil, and others.
• Pregnant patients - due to the unknown effects of high dose omega-3 fatty acids on the fetus.
• Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk, or patients who will not likely be able to comply with the study protocol.
• Bipolar patients receiving clozapine. These patients will be excluded due to the likelihood of extreme treatment resistance in clozapine-treated bipolar disorder. It may be unwise to discontinue the patient's clozapine, since recurrence may occur. Also, based on uncontrolled data, clozapine may be a uniquely effective mood stabilizer, which would add a potential confound to the study.
• Patients who meet DSM-IV criteria for substance abuse within 1 month of this trial or substance dependence within 3 months.