Changes in Adiposity, Metabolic Measures From Atypicals to Aripiprazole

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 78
• Participant gender: Both

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 clamps to characterize the metabolic effects of 12 weeks of aripiprazole treatment following chronic pretreatment with olanzapine, quetiapine, risperidone or ziprasidone.

We hypothesize that switching to aripiprazole treatment will induce improvements in total body adiposity, inflammation (e.g., high sensitivity C-reactive protein [hsCRP]), glucose metabolism (e.g., insulin sensitivity) and lipid metabolism (e.g., fasting plasma triglyceride), in comparison to chronic pretreatment with olanzapine, risperidone and quetiapine.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: Bristol-Myers Squibb
• Treatments: Aripiprazole; Olanzapine; Quetiapine Fumarate; Risperidone; Ziprasidone
• Last Updated: 2012-03-08

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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