Allopurinol Maintenance Study for Bipolar Disorder

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00732251
• Date of registration: 07/08/2008
• Prospective Registration: No
• Primary sponsor: Cedars-Sinai Medical Center
• Public title: Allopurinol Maintenance Study for Bipolar Disorder
• Scientific title: An Open Label, Naturalistic Study With Allopurinol Augmentation for Prevention of Mania in Bipolar Disorder
• Date of first enrolment: August 2008
• Target sample size: 15
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00732251
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Itai Danovitch, MD
• Affiliation: Cedars-Sinai Medical Center

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Mania

Bipolar Disorder

Mixed Mania

Intervention(s)

Drug: Allopurinol

Primary Outcome(s)

Number of Manic Episodes According to the Young Mania Rating Scale [Time Frame: 2 Years]

Secondary Outcome(s)

Number of Depressive Episodes Per Patient Visit According to the Hamilton Depression Scale [Time Frame: 2 years]

Number of Psychiatric Hospitalizations [Time Frame: 2 years]

Secondary ID(s)

IRB13414

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

West Coast College of Biological Psychiatry Inc

Results

• Results available: Yes
• Date Posted: 22/02/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00732251