Text Size

Body Mass Index (BMI) and Metabolic Changes Following Switch to Aripiprazole From Olanzapine, Risperidone and Quetiapine

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00312598
First received: April 6, 2006
Last updated: May 10, 2011
Last verified: May 2011
History of Changes
  Purpose

Weight gain is a serious, common side effect of many antipsychotic medications. On average, the highest amounts of weight gain are found to occur in people taking clozaril and olanzapine, but with significant weight gain occuring in those on the other atypical antipsychotics as well.

We, the researchers at the University of North Carolina, propose an open-label pilot study of the changes in weight, BMI, body composition, and lipids, glucose, insulin and other metabolic parameters occurring in subjects as they switch from treatment with olanzapine, risperidone or quetiapine to aripiprazole. We also will determine resting energy expenditure (REE) and respiratory quotient (RQ) as measured by metabolic cart to determine if either energy expenditure or the propensity to store energy as fat may be involved in any changes to weight that are detected. Food intake, hunger, and physical activity will also be assessed.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Mood Disorders
 Drug: aripiprazole
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Investigation of Body Mass Index, Body Composition, Resting Energy Expenditure, Respiratory Quotient and Metabolic Changes Following a Switch From Olanzapine, Quetiapine or Risperidone to Aripiprazole

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • BMI change [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Body composition change [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change in laboratory markers of cardiovascular and diabetes risk [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: August 2005
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: aripiprazole
    All subjects will be switched by cross-taper from their existing medication regime of either olanzapine,quetiapine,or risperidone to aripiprazole.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any ethnicity
  • Antipsychotic monotherapy with olanzapine, risperidone or quetiapine for minimum of 1 month at entry into study and with weight gain of 2 BMI units while on this medication or development of abnormalities of glucose (greater than 110 mg/dl fasting), lipids (total cholesterol [TC], high-density lipoprotein [HDL], triglycerides [TG], or low-density lipoprotein [LDL] greater than 10% change) or blood pressure (greater than 20 mmHg change in systolic or diastolic)
  • Antipsychotic monotherapy with aripiprazole is planned by the subject's treating psychiatrist.
  • Subjects able to fully participate in the informed consent process
  • Female subjects of childbearing potential must be using a medically accepted means of contraception which includes tubal ligation, hysterectomy, condoms, oral contraceptives, intrauterine device (IUD), cervical cap, diaphragm, transdermal contraceptive patch, and abstinence.

Exclusion Criteria:

  • Subjects have had a previous trial of aripiprazole
  • Serious or unstable medical illness which requires ongoing treatment with medication. This does not include non-insulin dependent diabetes, dyslipidemia or hypertension.
  • At serious suicidal risk.
  • Subjects with substance abuse or dependence.
  • Female subjects who are either pregnant or nursing.
  • Known history of mental retardation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00312598

Sponsors and Collaborators
University of North Carolina, Chapel Hill
Bristol-Myers Squibb
Investigators
Principal Investigator: Karen A Graham, MSc MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Karen Graham, Msc, MD/Principal Investigator, University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier: NCT00312598     History of Changes
Other Study ID Numbers: IND 70,111, GCRC 2086
Study First Received: April 6, 2006
Last Updated: May 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
schizophrenia
BMI
weight
 aripiprazole
antipsychotic
Mood Disorders with psychotic features

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Quetiapine
Olanzapine
Aripiprazole
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
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 17, 2013