Allopurinol Maintenance Study for Bipolar Disorder

NCT00732251 | Terminated Phase 4 Results

• 1 other identifier: IRB13414
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder; Mania; Mixed Mania

Keywords

Bipolar Disorder; Stable Bipolar Disorder; Mania; Mixed mania; Allopurinol

Outcome Measures

Primary Outcomes (1)

• Number of Manic Episodes According to the Young Mania Rating Scale

  Young Mania Rating Scale is an 11-item, clinician-administered scale to assess severity of manic symptoms before, during and after treatment. Four items are graded on a min. 0 to max. 8 scale (irritability, speech, thought content and disruptive/aggressive behavior) while the remaining 7 items are graded on a min. 0 to max. 4 scale. A score of 0 indicates behavior is absent and score of 4 or 8 indicates the behavior is present and severe. The change in score between Baseline and the Completion Visit will be reported. Ideally, the two time points will be Baseline and 6 Weeks after Baseline, but if a subject terminates early, the last Young Mania Rating Scale score will be used. The scores from each question are added for a total score ranging from min. 0 to max 60; higher scores indicate greater severity of symptoms. A score of 0-12 indicates the absence of mania or a very mild manic state, a score of 13-20 or higher indicates a mild manic episode, and over 20 indicates a manic state.

  2 Years

Secondary Outcomes (2)

• Number of Depressive Episodes Per Patient Visit According to the Hamilton Depression Scale

  2 years

• Number of Psychiatric Hospitalizations

  2 years

Study Arms (1)

Allopurinol

EXPERIMENTAL

Using an open label, naturalistic design, subjects will continue with their current psychiatric medications during the study. Allopurinol will be given at a fixed dose of 300 mg/day for the first week and then 600mg/d for the remainder of the study. Subjects who cannot tolerate the 600mg dose will be given a dose of 300mg/d. Subjects will participate in monthly follow up visits for 24 months. Subjects who develop a substance abuse or substance dependence disorder during the study will be terminated from the study. Also, subjects who develop a medical condition which can affect their mood stability will be terminated from the study.

Drug: Allopurinol

Interventions

Allopurinol DRUG

Allopurinol: 300-600 mg/day over a 24 month period

Also known as: Zyloprim, Aloprim

Allopurinol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be between ages 18 and 70.
• Subjects must meet diagnostic and statistical manual of mental disorders 4th edition criteria for bipolar disorder confirmed by the Mini International Neuropsychiatric Interview.
• Subjects must be taking at least one medication for mania at a therapeutic dose for at least 2 weeks.
• Subjects must have been diagnosed with bipolar disorder, type 1, for at least 2 years prior to baseline.
• 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.
• 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.
• Subjects must have had at least 1 manic episode in the 2 year period prior to entering the study.
• 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.
• 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.

You may not qualify if:

• 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 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.
• 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.)
• Subjects who develop substance abuse or dependence during participation in the study.
• Subjects taking azathioprine, mercaptopurine, apalcillin, and/or amoxicillin.
• Subjects who have been intoxicated with alcohol or drugs within the last 72hrs.
• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• West Coast College of Biological Psychiatry Inc: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Links

• Cedars-Sinai Medical Center Website

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Felicia Mayes
• Organization: Cedars Sinai Medical Center

mayesf@cshs.org

310-423-0825

Study Officials

• Itai Danovitch, MD

  Cedars-Sinai Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Psychiatry

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: October 2, 2019
• Results First Posted: February 22, 2018

Record last verified: 2019-10

Locations

US (1)