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Therapeutic Areas: Psychiatry/Psychology
Disease Category: Bipolar Disorders

Trial Information

Allopurinol Add-on Treatment for Refractory Mania: A Double-Blind, Placebo-Controlled Augmentation Study with Allopurinol for Treatment Resistant Mania

Bipolar disorder is a severe mental disorder with episodes of mania and depression. Current medications can have significant side effects, high costs, and require blood monitoring. The purpose of this study is to test the safety and effectiveness of allopurinol in combination with lithium, volproic acid, or carbamazepine for treatment-resistant bipolar mania and mixed mania. Allopurinol has been approved by the FDA as a treatment for calcium renal calculus, gout, and hyperunicemia but it has not been approved for use in treatment-resistant bipolar and mixed mania.

This placebo-controlled, double-blind study will involve 6 study visits over 7 weeks including a screening and baseline visit. During the screening visit a review of medical and psychiatric history as well as psychiatric assessments will be completed. A physical exam will be administered along with a blood draw and urine sample. At the baseline visit questionnaires concerning mood, disability, medications, and side effects will be completed. Vitals (blood pressure, heart rate, temperature and weight) will be measured and participants will be assigned to either the medication study group which will receive allopurinol or to the study group which will receive a placebo. At the 4 study visits, participants will be asked to complete questionnaires and vitals will be taken. In addition, blood will be drawn at the week 2 visit and a blood draw, urine sample collection and exit physical exam will be conducted at the week 6 (final) study visit.

Participants will continue taking their current medications at current doses throughout the study. Participants will be monitored by a study doctor throughout the research study. Participants will receive $40 for each research study visit with a total of $240 for completion of the entire study.

Patient Inclusion Criteria:

• Subjects must meet DSM-IV criteria for bipolar disorder, most recent episode manic or mixed, at the time of screening confirmed by the Mini International Neuropsychiatric Interview (MINI)
• Subjects must be taking medication for bipolar disorder for at least 4 weeks prior to study entry
• 18-70 years of age

Patient Exclusion Criteria:

• Subjects with a serious, unstable medical illness (such as cardiovascular, respiratory, neurologic, hematologic, renal, hepatic, endocrine, immunologic, or other systemic illness), a history of cerbrovascular disease, uncontrolled diabetes mellitus or AIDS. Subjects with chronic illness must be stable and otherwise physically healthy on the basis of a physical examination, medical history, electrocardiogram and the results of blood biochemistry, hematology tests and a urinalysis.
• Subjects with a history of substance abuse or dependence (excluding nicotine and caffeine) according to DSM-IV criteria within last 4 weeks.
• Subjects who have been intoxicated with alcohol or illicit drugs within 3 days prior to baseline
• Subjects with severe mood symptoms requiring hospitalization
• Subjects taking dopamine agonists and/or anti-psychotics
• Subjects with gout or renal insufficiency
• Subjects taking azathioprine, mercaptopurine, apalcillin, and/or amoxicillin
• Subjects with a history of severe pre-existing gastrointestinal narrowing or inability to swallow oral study medication whole with the aid of water
• Female subjects who are pregnant or nursing
• Subjects who have received an experimental drug or used an experimental medical device within 1 month of screening

For more information,

Lisa Glassman, Study Cooridnator
Cedars-Sinai Medical Center
8730 Alden Dr. Room E123
Los Angeles, CA 90048
Phone: 310-423-6515
Fax: 310-423-0888
EMail: glassmanl@cshs.org

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