Changes in Adiposity, Metabolic Measures From Atypicals to Aripiprazole
BMS
Changes in Adiposity and Metabolic Measures During Medication Switches to Aripiprazole From Other Atypical Antipsychotics
Sponsor study identifier
interventional
51
1 country
1
Study Start
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2009
Actual (reported)Study Completion
August 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 12, 2005
Actual (reported)September 20, 2005
Actual (reported)August 2009
Actual (reported)August 2009
Actual (reported)January 15, 2019
Actual (reported)Change in Total Body Fat (kg).
This study hypothesizes that switching to aripiprazole treatment will be associated with reductions in adipose tissue mass in comparison to olanzapine.
12 Weeks
Change in Whole Body Sensitivity (mg/kg/Min)
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.
12 Weeks
Subjects are randomized to stay on their current antipsychotic.
Subjects are randomized to switch to aripiprazole from their current antipsychotic.
Participants remain on their current antipsychotic.
Subjects are randomized to switch to aripiprazole from their current antipsychotic.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Haupt DW, Newcomer JW. Hyperglycemia and antipsychotic medications. J Clin Psychiatry. 2001;62 Suppl 27:15-26; discussion 40-1.
John W. Newcomer, MD
Washington University School of Medicine and Florida Atlantic University
51 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
A Placebo-Controlled, Cross-Over Trial of Aripiprazole
Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia
Contact the study team to confirm eligibility.
Primary Completion
August 2009
Actual (reported)Study Completion
August 2009
Actual (reported)Last Updated
January 15, 2019
Results First Posted
January 15, 2019
Record last verified: 2018-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: