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Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With Schizophrenia

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With Schizophrenia
Official Title  Aripiprazole for Clozapine Associated Medical Morbidity
Brief Summary

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.

Detailed Description

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.

Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Fasting lipids, including triglycerides and total cholesterol [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: Yes ]
Weight [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: Yes ]
Body Mass Index (BMI) [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: Yes ]
Insulin resistance and glucose metabolism [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  Food intake [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: Yes ]
Energy expenditure [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: Yes ]
Systematic Assessment for Treatment Emergent Effects (SAFTEE) [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: Yes ]
Plasminogen activator molecule-1 (PAI-1) [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: Yes ]
LDL particle size [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: Yes ]
C-reactive protein [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: Yes ]
Soluble intercellular adhesion molecule-1 [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: Yes ]
Lipid abnormalities [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: Yes ]
Condition  Schizophrenia
Insulin Resistance
Intervention  Drug: Aripiprazole
Drug: Placebo
MEDLINE PMIDs 12610718,   10479950,   10372689,   10831479,   12729864,   10517786,   12416594
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  70
Start Date  March 2005
Completion Date October 2009
Eligibility Criteria 

Inclusion Criteria:

  • Diagnosis of schizophrenia (any subtype) or schizoaffective disorder (any subtype)
  • Treatment with clozapine for at least 1 year
  • Stable dose of clozapine for at least 1 month
  • Well established compliance with outpatient medications
  • Female participants of non-childbearing potential or of childbearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study

Exclusion Criteria:

  • Current substance abuse
  • Psychiatrically unstable
  • Significant medical illness, including severe cardiovascular, hepatic, or renal disease
  • History of immunosuppression
  • Current or recent radiation or chemotherapy treatment for cancer
  • Chronic use of steroids
  • Pregnant or breastfeeding
Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Karina Tsatourian, PhD     617-912-7882     ktsatourian@partners.org    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00345033
Organization ID R01 MH72635
Secondary IDs †† DSIR 83-ATAP
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     David C. Henderson, MD     Massachusetts General Hospital    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date August 2008
First Received Date  June 23, 2006
Last Updated Date August 26, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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