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The Effects of Aripiprazole on Patients With Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00224822
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : March 24, 2010
Bristol-Myers Squibb
Information provided by:
New Mexico VA Healthcare System

Brief Summary:
The primary goal of this study is to assess the effect of aripiprazole on patients who developed metabolic syndrome while taking other second generation antipsychotic medications.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Bipolar Disorder Metabolic Syndrome X Drug: Aripiprazole Phase 4

Detailed Description:
Schizophrenia, schizoaffective disorder and bipolar disorder are severe and disabling disorders, associated with marked social or occupational dysfunction, tenfold suicidal risk, intensive healthcare resource utilization and poor prognosis. Atypical antipsychotics developed in the last decade are proving beneficial to a subset of patients. These agents share a reduced risk for EPS and tardive dyskinesia in comparison with first generation antipsychotics. They also appear to improve negative, cognitive, and depressive symptoms while being at least as efficacious as first generation "typical" drugs in controlling positive symptoms of schizophrenia and schizoaffective disorder. Unfortunately, during the late 1990's, case reports and studies began to document a number of adverse events associated with the use of most second generation antipsychotics such as weight gain, hyperlipidemia and hyperglycemia subsumed under the name "metabolic syndrome". Aripiprazole has a unique pharmacological mechanism, making this drug the ideal medication for treatment to patients who experience metabolic syndrome from other second generation antipsychotics. In numerous pervious trials, it has been demonstrated that aripiprazole is a safe and effective treatment for schizophrenia, schizoaffective disorder and bipolar disorder and that it may actually reduce plasma glucose levels and improve lipid profiles, lowering the risk for cardiovascular disease and /or diabetes. Thirty patients with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder who have experienced a 10 pound increase in weight while on a second generation antipsychotic or hyperlipidemia, or hyperglycemia, will switch to aripiprazole and be monitored for any improvement in BMI, lipids and glucose.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Aripiprazole on Patients With "Metabolic Syndrome": An Open-Label Trial
Study Start Date : March 2004
Actual Study Completion Date : March 2007

Primary Outcome Measures :
  1. The primary outcome assessment is weight gain/body mass index (BMI) compared to baseline
  2. Other primary outcomes with regard to efficacy will be scores on the Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impressions (CGI) compared to baseline.

Secondary Outcome Measures :
  1. Fasting lipids, glucose profiles and electrocardiogram (EKG) results compared to baseline to assess glucose, weight, lipids, and heart rhythms

Information from the National Library of Medicine

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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

Inclusion Criteria:

  • Males or females with DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder who, based on chart review, have developed significant weight gain or any clinically significant aspect of the metabolic syndrome including weight gain, hyperglycemia, diabetes, or hyperlipidemia, while on a second generation antipsychotic medication.
  • Between 18-65 years of age
  • Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker.
  • If female, must agree to use a medically approved contraceptive or does not possess potential to bear children

Exclusion Criteria:

  • History of adverse reaction to aripiprazole
  • Serious hepatic, renal, cardiac, neurological, or pulmonary disease that would prevent safe participation in a drug trial
  • A diagnosis of active drug or alcohol abuse according to DSM-IV criteria within the last 30 days
  • Suicidal or homicidal ideation or psychotic decompensation
  • Patients on Paxil, Remeron, tricyclic or monoamine oxidase inhibitor (MAOI) antidepressants or mood stabilizers other than lamotrigine.

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 identifier (NCT number): NCT00224822

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United States, New Mexico
New Mexico VA Healthcare System
Albuquerque, New Mexico, United States, 87108
Sponsors and Collaborators
New Mexico VA Healthcare System
Bristol-Myers Squibb
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Principal Investigator: Cynthia Geppert, MD, PhD New Mexico VA Healthcare System

Additional Information:
Layout table for additonal information Identifier: NCT00224822    
Other Study ID Numbers: VA-0001
BRINM #170
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: September 2007
Keywords provided by New Mexico VA Healthcare System:
Clinical Trial
Open Label
Schizoaffective Disorder
Bipolar Disorder
Metabolic Syndrome
Additional relevant MeSH terms:
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Metabolic Syndrome
Bipolar Disorder
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Bipolar and Related Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists