Status:
COMPLETED
Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With Schizophrenia
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Insulin Resistance
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 diagnosed 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 med...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00345033
Start Date
March 1 2005
End Date
October 1 2010
Last Update
June 23 2014
Active Locations (1)
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1
Massachusetts General Hospital Schizophrenia Program
Boston, Massachusetts, United States, 02114