Allopurinol Maintenance Study for Bipolar Disorder
Condition: Bipolar Disorder; Mania; Mixed Mania
MeSH terms: Mania; Bipolar Disorder
Intervention: Allopurinol
Intervention description: Allopurinol: 300-600 mg/day over a 24 month period
Intervention MeSH terms: Allopurinol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Bipolar Disorder; Stable Bipolar Disorder; Mania; Mixed mania; Allopurinol

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must be between ages 18 and 70.

          2. Subjects must meet diagnostic and statistical manual of mental disorders 4th edition
             criteria for bipolar disorder confirmed by the Mini International Neuropsychiatric
             Interview.

          3. Subjects must be taking at least one medication for mania at a therapeutic dose for at
             least 2 weeks.

          4. Subjects must have been diagnosed with bipolar disorder, type 1, for at least 2 years
             prior to baseline.

          5. Subjects must have adequate response to medications as evidenced by Young Mania Rating
             Scale score less than or equal to 10 at screening and at baseline.

          6. Subjects must have adequate response to medications as evidenced by Hamilton
             Depression Rating Scale score less than or equal to 10 at screening and at baseline.

          7. Subjects must have had at least 1 manic episode in the 2 year period prior to entering
             the study.

          8. 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.
             Acceptable methods of birth control during this study are regular use of contraceptive
             pills, intra-uterine devices, barrier methods or abstinence. Female subjects must also
             have a negative urine pregnancy test at screening, baseline and other time points
             throughout the study.

          9. Subjects must be able and willing to comply with self-administration of medication or
             have consistent help/support available.

         10. 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.

         11. Subjects must be able and willing to meet or perform study requirements (e.g. answer
             self-administered questionnaires).

         12. Subjects must be willing to allow study staff to contact subject's regular
             psychiatrist while the subject is in the study.

        Exclusion Criteria:

          1. Subjects who are unable to provide informed consent.

          2. 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 acquired immunodeficiency syndrome (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.

          3. Subjects who develop a medical condition during participation which can affect mood
             stability (i.e. seizure disorder, brain tumors, brain trauma, stroke, multiple
             sclerosis, etc.)

          4. Subjects who develop substance abuse or dependence during participation in the study.

          5. Subjects taking azathioprine, mercaptopurine, apalcillin, and/or amoxicillin.

          6. Subjects who have been intoxicated with alcohol or drugs within the last 72hrs.

          7. Subjects with a history of severe pre-existing gastrointestinal narrowing or inability
             to swallow oral study medication whole with the aid of water.

          8. Female subjects who are pregnant or nursing.

          9. Subjects who have previously participated in this study.

         10. Subjects with an anticipated life expectancy of 6 months or less.

         11. Subjects who have received an experimental drug or used an experimental medical device
             within 1 month of screening.