The Effects of Aripiprazole on Patients With Metabolic Syndrome

Schizophrenia Clinical Trial

Official title:

The Effects of Aripiprazole on Patients With "Metabolic Syndrome": An Open-Label Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224822
• Other study ID #: VA-0001
• Secondary ID: BRINM #170
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2005
• Last updated: March 23, 2010
• Start date: March 2004
• Est. completion date: March 2007

Study information

• Verified date: September 2007
• Source: New Mexico VA Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Metabolic Syndrome X
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Syndrome

Intervention

Drug:
• Aripiprazole

Locations

Country	Name	City	State
United States	New Mexico VA Healthcare System	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
New Mexico VA Healthcare System	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome assessment is weight gain/body mass index (BMI) compared to baseline
Primary	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	Fasting lipids, glucose profiles and electrocardiogram (EKG) results compared to baseline to assess glucose, weight, lipids, and heart rhythms

External Links

•   The New Mexico VA Healthcare System website
•   The website for the Biomedical Research Institute of New Mexico
•   The website for the University of New Mexico Human Research Review Committee which oversees the protection of human subjects for this project