Status:
COMPLETED
The Effects of Aripiprazole on Patients With Metabolic Syndrome
Lead Sponsor:
New Mexico VA Healthcare System
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00224822
Start Date
March 1 2004
End Date
March 1 2007
Last Update
March 24 2010
Active Locations (1)
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1
New Mexico VA Healthcare System
Albuquerque, New Mexico, United States, 87108