Phase 4
N=215
Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00423878 ↗Enrolled (actual)
215
Serious AEs
12.7%
Results posted
Dec 2012
Primary outcome: Primary: Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks — -20.2; -10.8 mg/dL non-HDL cholesterol
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Risperidone (Drug); Olanzapine (Drug); Quetiapine (Drug); Aripiprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Mental Health (NIMH)
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks |
-20.2; -10.8 | — |
| SECONDARY Efficacy Failure, Defined as Psychiatric Hospitalization, a 25 Percent Increase From Baseline on the Positive and Negative Syndrome Scale or Substantial Clinical Deterioration on the Clinical Global Impressions-Change (CGI-C) |
22; 18 | — |
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 risk of cardiovascular disease.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00423878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.