Changes in Adiposity, Metabolic Measures From Atypicals to Aripiprazole

Phase 4

Completed

• Conditions: Schizophrenia; Type 2 Diabetes Mellitus
• Interventions: Other: Switchers; Other: Stayers

• Registration Number: NCT00205660
• Lead Sponsor: Washington University School of Medicine

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

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 ketoacidosis) and long-term (e.g., vascular disease) complications.1-5As a result, cardiovascular (CV) mortality remains one of the leading causes of excess mortal...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2018-07
• Results First Submitted: 2018-07-20
• Results First Submitted QC: 2018-07-20
• Last Update Submitted: 2018-07-20
• Results First Posted: 2019-01-15
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Switchers	Switchers	Subjects are randomized to switch to aripiprazole from their current antipsychotic.
Stayers	Stayers	Subjects are randomized to stay on their current antipsychotic.

Primary Outcome Measures

Name	Time	Method
Change in Total Body Fat (kg).	12 Weeks	This study hypothesizes that switching to aripiprazole treatment will be associated with reductions in adipose tissue mass in comparison to olanzapine.
Change in Whole Body Sensitivity (mg/kg/Min)	12 Weeks	This study hypothesized that switching to aripiprazole treatment will be associated with statistically significant improvements in whole body sensitivity (mg/kg/min) in comparison to chronic pretreatment with olanzapine.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States