Bipolar Disorder Clinical Trial
Official title:
A Double-Blind, Placebo Controlled Augmentation Study With Allopurinol for Treatment Resistant Mania
NCT number | NCT00643123 |
Other study ID # | IRB8981 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | September 2007 |
Est. completion date | June 2010 |
Verified date | May 2019 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for treatment resistant mania and mixed mania.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center | National Alliance for Research on Schizophrenia and Depression |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Young Mania Rating Scale (YMRS) | The YMRS is an 11-item, clinician-administered rating scale to assess the severity of manic symptoms before, during and after treatment. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. A score of 0 indicates the behavior is absent, whereas a 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, his/her last YMRS score will be carried forward to the final visit. The scores from each question are added together to form a total score ranging from 0 to 60, with higher scores indicating a 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 man |
7 weeks (Baseline and 6 weeks (or last visit date) after baseline | |
Secondary | Hamilton Depression Scale (HAM-D) | The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered tool used to determine a patient's level of depression before, during, and after treatment. A 28-item HAM-D form was used but only the first 17 questions are used in the assessment for depression. Of the first 17 questions, eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. The sum of the scores from the first 17 questions is: 0-7 = normal, 8-13 = mild depression, 14-18 = moderate depression, 19-22=severe depression and = 23=very severe depression. Questions 18-28 are scored similarly and assess sleep disorders, paranoid behavior, motor dysfunction, psychosis, and weight gain, etc. |
7 weeks |
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