Allopurinol Add-on Treatment for Refractory Mania
Condition: Bipolar Disorder; Mixed Mania; Treatment-Resistant Mania
MeSH terms: Mania; Bipolar Disorder
Intervention: Allopurinol; Placebo
Intervention description: 300-600 mg/day over a 6 week period; Inactive substance
Intervention MeSH terms: Allopurinol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Bipolar Disorder; Mania; Mixed mania; Allopurinol; Treatment-Resistant mania

Summary:

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

Eligibility 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.