Clinical trial NCT00732251
Conditions: Bipolar Disorder Mania Mixed Mania
Keywords: Bipolar Disorder Stable Bipolar Disorder Mania Mixed mania Allopurinol
Sponsor: Cedars-Sinai Medical Center
Start date: 2008-08-01; Completion date: 2012-01-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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. Young Mania Rating Scale and Mini International Neuropsychiatric Interview 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. A manic episode will be defined by a Young Mania Rating Scale score ≥20.

Arms: arm 1: Using an open label, naturalistic design, subjects will continue with their current psychiatric medications during the study. Allopurinol will be given at a fixed dose of 300 mg/day for the first week and then 600mg/d for the remainder of the study. Subjects who cannot tolerate the 600mg dose will be given a dose of 300mg/d. Subjects will participate in monthly follow up visits for 24 months. Subjects who develop a substance abuse or substance dependence disorder during the study will be terminated from the study. Also, subjects who develop a medical condition which can affect their mood stability will be terminated from the study.
Interventions: intervention 1: Allopurinol
Intervention descriptions: intervention 1: Allopurinol: 300-600 mg/day over a 24 month period

Protocol documents: