The Effects of Aripiprazole on Patients With Metabolic Syndrome

NCT00224822 | Completed Phase 4 DMC

• 2 other identifiers: VA-0001BRINM #170
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Metabolic Syndrome X

Keywords

Psychiatry; Antipsychotic; Psychopharmacology; Clinical Trial; Open Label; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Fasting lipids, glucose profiles and electrocardiogram (EKG) results compared to baseline to assess glucose, weight, lipids, and heart rhythms

Interventions

Aripiprazole DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Mexico VA Healthcare System: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

New Mexico VA Healthcare System

Albuquerque, New Mexico, 87108, United States

Location

Related Links

• The New Mexico VA Healthcare System website
• The website for the Biomedical Research Institute of New Mexico

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Metabolic Syndrome

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Cynthia Geppert, MD, PhD

  New Mexico VA Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 23, 2005
• Study Start: March 1, 2004
• Study Completion: March 1, 2007
• Last Updated: March 24, 2010

Record last verified: 2007-09

Locations

US (1)