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

This study is currently recruiting participants.

Verified by The University of North Carolina, Chapel Hill, March 2009

First Received: April 6, 2006 Last Updated: March 5, 2009 History of Changes

Sponsors and Collaborators:	The University of North Carolina, Chapel Hill Bristol-Myers Squibb
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00312598

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 IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Quetiapine Quetiapine fumarate Aripiprazole Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
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

Further study details as provided by The 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 ]

Estimated Enrollment:	30
Study Start Date:	August 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

All subjects will be switched by cross-taper from their existing medication regime of either olanzapine,quetiapine,or risperidone to aripiprazole.

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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

Contacts

Contact: Brenda Pearson, LCSW

919-843-8084

bpearson@med.unc.edu

Locations

United States, North Carolina
University of North Carolina at Chapel Hill	Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Brenda Pearson, LCSW 919-843-8084 bpearson@med.unc.edu
Principal Investigator: Karen A Graham, MSc MD

Sponsors and Collaborators

The University of North Carolina, Chapel Hill

Bristol-Myers Squibb

Investigators

Principal Investigator:

Karen A Graham, MSc MD

The University of North Carolina, Chapel Hill

More Information

No publications provided

Responsible Party:	University of North Carolina at Chapel Hill ( Karen Graham, Msc, MD/Principal Investigator )
Study ID Numbers:	IND 70,111, GCRC 2086
Study First Received:	April 6, 2006
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00312598 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of North Carolina, Chapel Hill:

schizophrenia
BMI
weight

aripiprazole
antipsychotic
Mood Disorders with psychotic features

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Psychotropic Drugs
Olanzapine
Risperidone
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Serotonin
Body Weight

Schizophrenia
Quetiapine
Dopamine
Mental Disorders
Mood Disorders
Dopamine Agents
Psychotic Disorders
Peripheral Nervous System Agents
Aripiprazole
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Schizophrenia
Serotonin Antagonists
Pathologic Processes
Mental Disorders
Therapeutic Uses
Psychotic Disorders
Aripiprazole
Schizophrenia and Disorders with Psychotic Features

Disease
Tranquilizing Agents
Gastrointestinal Agents
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Quetiapine
Serotonin Agents
Autonomic Agents
Mood Disorders
Dopamine Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009