Overview

Allopurinol Add-on Treatment for Refractory Mania

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for treatment resistant mania and mixed mania.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Treatments:
Allopurinol
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.