Allopurinol Add-on Treatment for Refractory Mania

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for treatment resistant mania and mixed mania.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Collaborator: National Alliance for Research on Schizophrenia and Depression
• Treatments: Allopurinol

Criteria

Inclusion Criteria:

• Subjects must be between ages 18 and 70.

• 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 at least one medication for mania (lithium, valproic acid, carbamazepine) at a therapeutic dose for at least 4 weeks.

• Subjects must have non-response or partial response to medications as evidenced by Young Mania Rating Scale (YMRS) score greater than or equal to 14 at screening and at baseline.

• Female subjects must be either postmenopausal for at least 1 year, surgically sterile, abstinent or practicing an effective method of birth control if sexually active. Female subjects must also have a negative urine pregnancy test at screening, baseline and other time points throughout the study.

• Subjects must be able and willing to comply with self-administration of medication or have consistent help/support available.

• Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

• Subjects must be able and willing to meet or perform study requirements (e.g. answer self-administered questionnaires).

• Subjects must be willing to allow study staff to contact subject's regular psychiatrist while the subject is in the study.

Exclusion Criteria:

• Subjects who are unable to provide informed consent.

• Subjects with a serious, unstable medical illness (such as cardiovascular, respiratory, neurologic, hematologic, renal, hepatic, endocrine, immunologic, or other systemic illness), a history of cerebrovascular 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 taking azathioprine, mercaptopurine, apalcillin, and/or amoxicillin.

• Subjects taking dopamine agonists and/or anti-psychotics.

• Subjects who have been intoxicated with alcohol or illicit drugs within 3 days prior to baseline.

• 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 previously participated in this study.

• Subjects with an anticipated life expectancy of 6 months or less.

• Subjects who have received an experimental drug or used an experimental medical device within 1 month of screening.