The Effects of Aripiprazole on Patients With Metabolic Syndrome

New Mexico VA Healthcare System

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Bipolar Disorder

Schizoaffective Disorder

Metabolic Syndrome X

Treatments

Drug: Aripiprazole

Study type

Interventional

Funder types

Other U.S. Federal agency

Industry

Identifiers

NCT00224822

BRINM #170

VA-0001

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.