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Allopurinol Maintenance Study for Bipolar Disorder
This study is currently recruiting participants.
Verified by Cedars-Sinai Medical Center, February 2009
First Received: August 7, 2008   Last Updated: February 3, 2009   History of Changes
Sponsors and Collaborators: Cedars-Sinai Medical Center
West Coast College of Biological Psychiatry
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00732251
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Mania
Mixed Mania
Drug: Allopurinol
Phase IV

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Allopurinol sodium Allopurinol
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Open Label, Single Group Assignment
Official Title: An Open Label, Naturalistic Study With Allopurinol Augmentation for Prevention of Mania in Bipolar Disorder

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Young Mania Rating Scale (YMRS) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Depression Scale (HAM-D) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2008
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: Allopurinol
Allopurinol : 300-600 mg/day over a 4 week period

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 (MINI). YMRS and MINI 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. We will also measure the changes in medication doses that subjects in each group need to maintain mood stability.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must be between ages 18 and 70.
  2. Subjects must meet DSM-IV criteria for bipolar disorder confirmed by the Mini International Neuropsychiatric Interview (MINI).
  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 (YMRS) 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 (HAM-D) 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732251

Contacts
Contact: Lisa H Glassman, B.A. 310-423-0735 glassmanL@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
West Coast College of Biological Psychiatry
Investigators
Principal Investigator: Alexander Fan, M.D. Cedars-Sinai Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Cedars-Sinai Medical Center, Department of Psychiatry and Behavioral Neuroscience ( Dr. Alexander Fan, M.D. )
Study ID Numbers: IRB13414
Study First Received: August 7, 2008
Last Updated: February 3, 2009
ClinicalTrials.gov Identifier: NCT00732251     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Cedars-Sinai Medical Center:
Bipolar Disorder
Stable Bipolar Disorder
Mania
Mixed mania
Allopurinol

Study placed in the following topic categories:
Antimetabolites
Allopurinol
Affective Disorders, Psychotic
Antioxidants
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders
Antirheumatic Agents

Additional relevant MeSH terms:
Antimetabolites
Allopurinol
Antioxidants
Disease
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Enzyme Inhibitors
Protective Agents
Gout Suppressants
Pharmacologic Actions
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Free Radical Scavengers
Mood Disorders
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009