The Effects of Aripiprazole on Patients With Metabolic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2007-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia Schizoaffective Disorder Bipolar Disorder Metabolic Syndrome X

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Aripiprazole

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No