Status:
COMPLETED
Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The study will compare the effectiveness of antipsychotic medications for patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased ...
Detailed Description
Metabolic abnormalities associated with cardiovascular morbidity and premature mortality are more common in patients with schizophrenia than in matched controls. Although there is some evidence that p...
Eligibility Criteria
Inclusion
- Diagnosed with schizophrenia or schizoaffective disorder
- Currently treated with olanzapine, quetiapine or risperidone
- BMI greater than or equal to 27
- Non-HDL cholesterol greater than or equal to 130 mg/dL (if non-HDL cholesterol is between 130 - 139 mg/dL, then LDL cholesterol must be greater than 100 mg/dL).
Exclusion
- Diabetes (FBS greater than or equal to 126) or treatment with oral hypoglycemic drug or insulin
- Non-HDL cholesterol greater than 300 mg/dL
- Serum triglycerides greater than 500 mg/dL
- Patients in the first episode of schizophrenia or schizoaffective disorder
- Known hypersensitivity to aripiprazole
- On weight loss medications
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT00423878
Start Date
January 1 2007
End Date
March 1 2010
Last Update
November 2 2016
Active Locations (28)
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1
SHANTI Clinical Trials
Colton, California, United States, 92324
2
Stanford University
Palo Alto, California, United States, 94305
3
Yale University
New Haven, Connecticut, United States, 06519
4
Mental Health Advocates
Boca Raton, Florida, United States, 33431