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Sponsors and Collaborators: |
Cedars-Sinai Medical Center West Coast College of Biological Psychiatry |
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Information provided by: | Cedars-Sinai Medical Center |
ClinicalTrials.gov Identifier: | NCT00732251 |
The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for the prevention of mania in bipolar disorder patients with currently stable mood.
Condition | Intervention | Phase |
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Bipolar Disorder Mania Mixed Mania |
Drug: Allopurinol |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Single Group Assignment |
Official Title: | An Open Label, Naturalistic Study With Allopurinol Augmentation for Prevention of Mania in Bipolar Disorder |
Estimated Enrollment: | 20 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: Allopurinol
Allopurinol : 300-600 mg/day over a 4 week period
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The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for the prevention of mania in bipolar disorder patients with currently stable mood. Bipolar disorder is a mental disorder with severe mood swings (mania and depression). Despite the development of medications for mania, they may have significant side effects, high costs and the need for serum level monitoring. These factors adversely affect medication compliance in bipolar patients. One recent study indicated the efficacy of allopurinol in the treatment of bipolar mania. Our hypothesis is that the addition of allopurinol to standard medications for bipolar disorder will decrease the recurrences of manic episodes compared to standard medications.
This study will recruit bipolar disorder patients currently mood stable on a therapeutic dose of an anti-manic medication. Stable mood will be defined as a Young Mania Rating Scale score ≤10 and Hamilton Depression Rating Scale ≤10. Subjects must have a diagnosis of bipolar disorder confirmed by the Mini International Neuropsychiatric Interview (MINI). YMRS and MINI are common research questionnaires used in bipolar disorder studies. Potential subjects will be identified and approached during an outpatient clinical visit by a member of the research team and identified by their treating physicians and referred to the researchers.
This study involves adding allopurinol to subjects' current bipolar medications. This study will be a open label, naturalistic study. The subject will be examined monthly for manic symptoms for 2 years. Semi-structured interviews and study questionnaires will be administered to subjects at each visit.
Monthly Follow-up Study Visits (once per month for 2 years - Months 1-5, 7-11, 13-17, 19-23) may be conducted either in-person or over the phone. All of the questionnaires will be administered by a clinician if the visit is completed over the phone. However, the 6-month interval visits (Months 6, 12, 18, and 24) must be done at the research center.
The primary outcome measure will be the number of manic episodes in the 2 year study period. We will also measure the changes in medication doses that subjects in each group need to maintain mood stability.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa H Glassman, B.A. | 310-423-0735 | glassmanL@cshs.org |
United States, California | |
Cedars-Sinai Medical Center | Recruiting |
Los Angeles, California, United States, 90048 |
Principal Investigator: | Alexander Fan, M.D. | Cedars-Sinai Medical Center |
Responsible Party: | Cedars-Sinai Medical Center, Department of Psychiatry and Behavioral Neuroscience ( Dr. Alexander Fan, M.D. ) |
Study ID Numbers: | IRB13414 |
Study First Received: | August 7, 2008 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00732251 History of Changes |
Health Authority: | United States: Federal Government |
Bipolar Disorder Stable Bipolar Disorder Mania Mixed mania Allopurinol |
Antimetabolites Allopurinol Affective Disorders, Psychotic Antioxidants Mental Disorders |
Bipolar Disorder Mood Disorders Psychotic Disorders Antirheumatic Agents |
Antimetabolites Allopurinol Antioxidants Disease Molecular Mechanisms of Pharmacological Action Bipolar Disorder Physiological Effects of Drugs Enzyme Inhibitors Protective Agents |
Gout Suppressants Pharmacologic Actions Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Free Radical Scavengers Mood Disorders Antirheumatic Agents |