The Effects of Aripiprazole on Patients With Metabolic Syndrome

Completed · Phase 4

Conditions studied: Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Metabolic Syndrome X

In brief

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.

Key facts

Study ID

NCT00224822

Run by

New Mexico VA Healthcare System

People needed

27

Starts

2004-03-01

Expected to finish

2007-03-01

Last updated by the study team

2010-03-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• New Mexico VA Healthcare System — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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