The Effects of Aripiprazole on Patients With Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
New Mexico VA Healthcare System
ClinicalTrials.gov Identifier:
NCT00224822
First received: September 21, 2005
Last updated: March 23, 2010
Last verified: September 2007
  Purpose

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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Metabolic Syndrome X
Drug: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Aripiprazole on Patients With "Metabolic Syndrome": An Open-Label Trial

Resource links provided by NLM:


Further study details as provided by New Mexico VA Healthcare System:

Primary Outcome Measures:
  • The primary outcome assessment is weight gain/body mass index (BMI) compared to baseline
  • 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:
  • Fasting lipids, glucose profiles and electrocardiogram (EKG) results compared to baseline to assess glucose, weight, lipids, and heart rhythms

Enrollment: 27
Study Start Date: March 2004
Study Completion Date: March 2007
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.

  Eligibility

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

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.
  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: NCT00224822

Locations
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
Investigators
Principal Investigator: Cynthia Geppert, MD, PhD New Mexico VA Healthcare System
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00224822     History of Changes
Other Study ID Numbers: VA-0001, BRINM #170
Study First Received: September 21, 2005
Last Updated: March 23, 2010
Health Authority: United States: Federal Government

Keywords provided by New Mexico VA Healthcare System:
Psychiatry
Antipsychotic
Psychopharmacology
Clinical Trial
Open Label
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Metabolic Syndrome

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Schizophrenia
Metabolic Syndrome X
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 28, 2014