At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with schizophrenia per DSM-IV criteria
- ✓Age 18-60 years or older
- ✓Currently treated with olanzapine, quetiapine, risperidone, or ziprasidone for ≥3 months before enrollment
- ✓Able to provide informed consent
- ✕Pregnant or breastfeeding
- ✕Substance abuse or dependence within past 6 months per DSM-IV
- ✕Involuntary legal status per Missouri law
- ✕Serious medical disorder that may confound symptom assessment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Changes in Adiposity and Metabolic Measures During Medication Switches to Aripiprazole From Other Atypical Antipsychotics
In Brief
A Phase 4 clinical trial evaluating Stayers and Switchers for Schizophrenia and Type 2 Diabetes Mellitus. Completed, enrolled 51 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Participants remain on their current antipsychotic.
Subjects are randomized to switch to aripiprazole from their current antipsychotic.