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

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ClinicalTrials.gov Identifier: NCT00312598
Recruitment Status : Completed
First Posted : April 10, 2006
Last Update Posted : January 13, 2014
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Karen Graham, MD, University of North Carolina, Chapel Hill

Brief Summary:

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 observational, 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. This medication switch will be determined prior to their entering this study by their treating psychiatrist. 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 or disease Intervention/treatment
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Mood Disorders Drug: Aripiprazole

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : August 2005
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
aripiprazole
observational measures of metabolic parameters of subjects who are making clinically determined medication switch to aripiprazole
Drug: Aripiprazole
Other Name: Abilify




Primary Outcome Measures :
  1. BMI change [ Time Frame: 12 weeks ]
  2. Body composition change [ Time Frame: 12 weeks ]
  3. Change in laboratory markers of cardiovascular and diabetes risk [ Time Frame: 12 weeks ]

Biospecimen Retention:   Samples Without DNA
serum collected at baseline and end of study to be assayed in the future for related metabolic tests which are not specified at this time.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Psychiatry outpatient clinic
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312598


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

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Responsible Party: Karen Graham, MD, associate professor of psychiatry, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00312598     History of Changes
Other Study ID Numbers: IND 70,111
GCRC 2086
First Posted: April 10, 2006    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014
Keywords provided by Karen Graham, MD, University of North Carolina, Chapel Hill:
schizophrenia
BMI
weight
aripiprazole
antipsychotic
Mood Disorders with psychotic features
Additional relevant MeSH terms:
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Aripiprazole
Disease
Schizophrenia
Psychotic Disorders
Mood Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Risperidone
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Dopamine Agonists
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists
Antiemetics
Autonomic Agents