The Effects of Aripiprazole on Patients With Metabolic Syndrome

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Mexico VA Healthcare System
• Collaborator: Bristol-Myers Squibb
• Treatments: Aripiprazole

Criteria

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.