Allopurinol Add-on Treatment for Refractory Mania

Completed · Phase 4 · Has a placebo group

Conditions studied: Bipolar Disorder, Mixed Mania, Treatment-Resistant Mania

In brief

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

Key facts

Study ID

NCT00643123

Run by

Cedars-Sinai Medical Center

People needed

40

Starts

2007-09-01

Expected to finish

2010-06-01

Last updated by the study team

2019-05-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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