Overview

The Effect of Switching to Aripiprazole on Heart Health in Overweight and Obese Patients With Schizophrenia

Status:
Completed
Trial end date:
2005-12-01
Target enrollment:
0
Participant gender:
All
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 examines the safety of switching to aripiprazole with respect to changes in the clinical state, preexisting or emergent side-effects, how the brain processes information and changes in social functioning and quality of life.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
Bristol-Myers Squibb
Treatments:
Aripiprazole
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.