Status:
COMPLETED
Changes in Adiposity, Metabolic Measures From Atypicals to Aripiprazole
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Schizophrenia
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
This proposal aims to use well-validated methodologies such as dual energy x-ray absorptiometry (DEXA), frequently sampled oral glucose tolerance tests (fsOGTTs), and hyperinsulinemic euglycemic clamp...
Detailed Description
Schizophrenia is associated with increased rates of obesity, hyperglycemia, dyslipidemia and type 2 diabetes mellitus (T2DM), causing increased morbidity and mortality due to acute (e.g., diabetic ket...
Eligibility Criteria
Inclusion
- Patient meets DSM-IV criteria for Schizophrenia
- 18-60 years of age or older
- Able to give informed consent
- Treated with olanzapine, quetiapine, risperidone or ziprasidone for greater than or equal to 3 months prior to enrollment
Exclusion
- pregnant or breastfeeding women will be excluded
- Meets DSM-IV criteria for substance abuse or dependence within past 6 months
- involuntary legal status (as per Missouri law)
- any serious medical disorder that may confound assessment of symptoms
- subjects taking prescription medications except psychotropic meds
- meets DSM-IV criteria for Mental Retardation (mild or worse)
- Subjects taking tricyclic antidepressants or mood stabilizers
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00205660
Start Date
February 1 2005
End Date
August 1 2009
Last Update
January 15 2019
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110