Changes in Adiposity, Metabolic Measures From Atypicals to Aripiprazole

This study is currently recruiting participants.

Verified by Washington University School of Medicine, October 2007

Sponsors and Collaborators:	Washington University School of Medicine Bristol-Myers Squibb
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00205660

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Type 2 Diabetes Mellitus	Drug: control Drug: aripiprazole	Phase IV

MedlinePlus related topics: Diabetes Obesity Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Changes in Adiposity and Metabolic Measures During Medication Switches to Aripiprazole From Other Atypical Antipsychotics

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Improvement in Total Body Adiposity at 12 weeks
Improvement in high sensitivity C-reactive protein @ 12 wks
Improvement in glucose metabolism @ 12 wks
Improvement in lipid metabolism @ 12 wks

Estimated Enrollment:	88
Study Start Date:	February 2005
Estimated Study Completion Date:	October 2008

Arms	Assigned Interventions
1: Active Comparator control	Drug: control
2: Active Comparator aripiprazole	Drug: aripiprazole

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205660

Contacts

Contact: Julie Schweiger, BA, CCRC	314-362-3153	schweigj@psychiatry.wustl.edu
Contact: Karen Flavin, RN, CCRC	314-362-5242	flavinka@psychiatry.wustl.edu

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Brenda Rosen 314-362-5939 rosenb@psychiatry.wustl.edu
Contact: Amber Spies 314-362-2465 spiesa@psychiatry.wustl.edu
Principal Investigator: John W. Newcomer, MD
Sub-Investigator: Dan Haupt, MD

Sponsors and Collaborators

Washington University School of Medicine

Bristol-Myers Squibb

Investigators

Principal Investigator:

John W. Newcomer, MD

Washington University School of Medicine

More Information

Publications:

Haupt DW, Newcomer JW. Hyperglycemia and antipsychotic medications. J Clin Psychiatry. 2001;62 Suppl 27:15-26; discussion 40-1. Review.

Study ID Numbers:	BMS #942370
Study First Received:	September 12, 2005
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00205660
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

Schizophrenia
Obesity
Hyperglycemia
Dyslipidemia
Type 2 Diabetes Mellitus

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Schizophrenia
Hyperglycemia
Mental Disorders
Diabetes Mellitus, Type 2

Psychotic Disorders
Aripiprazole
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Dyslipidemias
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009