Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With Schizophrenia
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Aripiprazole for Clozapine Associated Medical Morbidity|
- Change in Total Cholesterol [ Time Frame: Measured at Baseline and Week 8 ] [ Designated as safety issue: Yes ]A comparison of aripiprazole group and placebo group in change in total cholesterol measured at Baseline and Week 8.
- Change in Weight [ Time Frame: Measured at Baseline and Week 8 ] [ Designated as safety issue: Yes ]A comparison between aripiprazole group and placebo group in change in weight measured at Baseline and Week 8.
- Change in Body Mass Index (BMI) [ Time Frame: Measured at Baseline and Week 8 ] [ Designated as safety issue: Yes ]A comparison between aripiprazole group and placebo group of change in Body Mass Index (BMI) measured at Baseline and Week 8.
- Change in Glucose Metabolism [ Time Frame: Measured at Baseline and Week 8 ] [ Designated as safety issue: Yes ]A comparison between the aripiprazole group and placebo group in change in glucose metabolism measured at Baseline and Week 8.
- Change in Triglycerides [ Time Frame: Measured at Baseline and Week 8 ] [ Designated as safety issue: Yes ]
- Change in Insulin Resistance [ Time Frame: Measured at Baseline and Week 8 ] [ Designated as safety issue: Yes ]A comparison between aripiprazole group and placebo group of change in insulin resistance measured at Baseline and Week 8.
|Study Start Date:||March 2005|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Participants will take aripiprazole 15mg/day for 8 weeks.
15-mg dose once a day for 8 weeks
Placebo Comparator: 2
Participants will take placebo for 8 weeks.
1 tablet placebo dose once a day for 8 weeks
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 8-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 follow-up 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 8 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 8, 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345033
|United States, Massachusetts|
|Massachusetts General Hospital Schizophrenia Program|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||David C. Henderson, MD||Massachusetts General Hospital|