Status:
WITHDRAWN
Cardio Risk of Acute Schizophrenia Olanzapine Duke
Lead Sponsor:
Duke University
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Primary Objective: To compare added metformin and/or added simvastatin versus no intervention in reducing or eliminating increased cardiovascular risk (as estimated by elevation in non-HDL cholesterol...
Detailed Description
Olanzapine offers greater therapeutic antipsychotic benefit than the other non-clozapine antipsychotic medications available in the U.S., making it a desirable choice for the long-term maintenance tre...
Eligibility Criteria
Inclusion
- We will include patients who come to us free of antipsychotic medication, i.e., patients with chronic schizophrenia (with at least one prior psychiatric hospitalization) who have been off antipsychotic medication for at least 3 weeks and who are newly hospitalized for treatment of an acute psychotic relapse; these patients will be male or female, 18-60 years of age, meet DSM-IV criteria for schizophrenia, and have scores \>=4 on at least two of the PANSS Positive subscale items.
Exclusion
- We will exclude patients whose psychoses are predominantly affective in nature or explainable on the basis of substance abuse or a co-morbid medical condition, patients with diabetes mellitus, epilepsy, mental retardation, or organic mental syndromes, and patients currently taking metformin or a statin.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00672464
Start Date
April 1 2008
End Date
February 1 2010
Last Update
July 31 2014
Active Locations (2)
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1
John Umstead Hospital
Butner, North Carolina, United States, 27509
2
Duke University Medical Center
Durham, North Carolina, United States, 27705