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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00345033 |
This study will evaluate the effects of combination treatment with aripiprazole and clozapine on insulin resistance, blood fat levels, and weight gain in people with schizophrenia.
Condition | Intervention | Phase |
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Schizophrenia Insulin Resistance |
Drug: Aripiprazole Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Aripiprazole for Clozapine Associated Medical Morbidity |
Estimated Enrollment: | 70 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will take aripiprazole for 8 weeks.
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Drug: Aripiprazole
15-mg dose once a day for 8 weeks
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2: Placebo Comparator
Participants will take placebo for 8 weeks.
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Drug: Placebo
15-mg dose once a day for 8 weeks
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Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations and delusions, as well as overall difficulty with everyday functioning. Although the medications available to treat the disorder are generally effective, many cause undesirable side effects. Clozapine, for example, is a strong tranquilizer that functions like an antipsychotic medication. It has been shown to be effective in reducing the symptoms of schizophrenia, but can bring about serious side effects, including heart failure, weight gain, and diabetes. Aripiprazole, an atypical antipsychotic medication, has been shown to have fewer side effects than older antipsychotic drugs. The addition of aripiprazole to a clozapine treatment regimen may reduce the negative side effects of clozapine. This study will evaluate the effects of combination treatment with aripiprazole and clozapine on insulin resistance, blood fat levels, and weight gain in people with schizophrenia.
Individuals interested in participating in this 12-week, double-blind study will first attend a screening session at the study site. Medical and psychiatric evaluations will be completed, blood samples will be taken, and an EKG will be performed. Eligible participants will undergo baseline assessments and then be randomly assigned to receive either aripiprazole or placebo in addition to their prescribed dose of clozapine. Participants will take one 15-mg capsule of their assigned medication once a day for 8 weeks. Study visits will occur biweekly for the first 8 weeks, followed by one final visit at Week 12. At each study visit, medication will be distributed, and the following criteria will be assessed: vital signs; weight; complete blood count; medication side effects; and extrapyramidal symptoms (EPS), which are potential neurological side effects of antipsychotic medications and may include involuntary movements, tremors, and rigidity. The Week 12 follow-up visit will include an EKG, and assessments of the following criteria: vital signs; medication side effects; treatment efficacy; blood counts; weight and height; and waist and hip circumference. At baseline and Week 12, participants will also undergo a frequently sampled intravenous glucose tolerance test (FSIVGTT). This involves intravenous infusion of glucose followed by frequent blood sampling to measure insulin and glucose concentrations. During the 4 days prior to each FSIVGTT, participants will record their food intake and wear an activity monitor.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Karina Tsatourian, PhD | 617-912-7882 | ktsatourian@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital Schizophrenia Program | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Leah B. Namey Briggs, BS 617-912-7800 lbriggs@partners.org | |
Principal Investigator: David C. Henderson, MD |
Principal Investigator: | David C. Henderson, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital Freedom Trail Clinic ( David C. Henderson, MD ) |
Study ID Numbers: | R01 MH72635, DSIR 83-ATAP |
Study First Received: | June 23, 2006 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00345033 |
Health Authority: | United States: Federal Government |
Glucose Metabolism |
Schizophrenia Hyperinsulinism Metabolic Diseases Mental Disorders Clozapine Psychotic Disorders |
Aripiprazole Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Schizophrenia and Disorders with Psychotic Features |
Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |