The Effects of Aripiprazole on Patients With Metabolic Syndrome

Sponsor

New Mexico VA Healthcare System (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00224822

Collaborator

Bristol-Myers Squibb (Industry)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Mar 1, 2004

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.