Changes in Adiposity, Metabolic Measures From Atypicals to Aripiprazole

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00205660
First received: September 12, 2005
Last updated: March 8, 2012
Last verified: March 2012
  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: ziprasidone
Drug: risperidone
Drug: olanzapine
Drug: quetiapine
Drug: aripiprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Changes in Adiposity and Metabolic Measures During Medication Switches to Aripiprazole From Other Atypical Antipsychotics

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Improvement in Total Body Adiposity at 12 weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Improvement in high sensitivity C-reactive protein @ 12 wks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Improvement in glucose metabolism @ 12 wks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Improvement in lipid metabolism @ 12 wks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: February 2005
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: olanzapine
Subject's current use
Drug: olanzapine
Subject's are randomized to continue current olanzapine or switch to aripiprazole
Drug: aripiprazole
Participants randomized to stay on current treatment (olanzapine) or switch to aripiprazole.
Active Comparator: ziprasidone
Subjects current use
Drug: ziprasidone
Subjects are randomized to continue current ziprasidone or to switch to aripiprazole
Drug: aripiprazole
participants randomized to stay on current treatment (ziprasidone) or switch to aripiprazole
Active Comparator: risperidone
Subject's current use
Drug: risperidone
Subjects are randomized to continue current risperidone or to switch to aripiprazole
Drug: aripiprazole
Participants randomized to stay on current treatment (risperidone) or switch to aripiprazole
Active Comparator: quetiapine
Subject's current use
Drug: quetiapine
Subject's are randomized to continue current use of quetiapine or switch to aripiprazole
Drug: aripiprazole
Participants are randomized to either stay on their current treatment (quetiapine) or switch to 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
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:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00205660     History of Changes
Other Study ID Numbers: BMS #942370
Study First Received: September 12, 2005
Last Updated: March 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Schizophrenia
Obesity
Hyperglycemia
Dyslipidemia
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Schizophrenia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Ziprasidone
Aripiprazole
Quetiapine
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014