Status:
COMPLETED
The Effect of Switching to Aripiprazole on Heart Health in Overweight and Obese Patients With Schizophrenia
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Overweight
Hyperlipidemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This is a 2-year study proposing to examine the effects of aripiprazole on heart health factors such as serum lipids, serum leptin, fasting blood sugar, body weight and blood pressure. This study also...
Detailed Description
This is a 2-yr study proposing to examine the effects of switching subjects from conventional and atypical antipsychotic agents to Aripiprazole on cardiovascular health indices in overweight and obese...
Eligibility Criteria
Inclusion
- Male and female subjects ages 18-65 years
- Outpatients and stable partial hospital patients
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia or schizoaffective disorder
- No psychiatric hospitalization in 30 days prior to study start
- Partially remitted patients with a PANSS score below 100 at screening
- Currently on a stable dose of only one antipsychotic for at least 30 days prior to study start
- Currently receiving a stable dose of all other psychotropic medications for at least 30 days prior to study start
- BMI greater than 26
- Female patients of childbearing age must be using an acceptable method of birth control for at least 1 month prior to participation in the research study and continue for at least 4 weeks after the final study visit.
- Ability to provide informed consent.
Exclusion
- Mental retardation
- Current treatment with clozapine
- Currently enrolled in a weight management program or receiving pharmacological treatment for weight reduction
- Serious or unstable medical illness
- Female patients who are pregnant, lactating, or plan to become pregnant during the study period
- Concurrently receiving treatment with ketoconazole, quinidine, carbamazepine.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00222833
Start Date
October 1 2004
End Date
December 1 2005
Last Update
January 15 2008
Active Locations (1)
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1
Western Psychiatric Institute and Clinic of UPMC
Pittsburgh, Pennsylvania, United States, 15213