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

Completed · Phase 4

Conditions studied: Overweight, Hyperlipidemia, Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT00222833

Run by

University of Pittsburgh

People needed

30

Starts

2004-10-01

Expected to finish

2005-12-01

Last updated by the study team

2008-01-15

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Western Psychiatric Institute and Clinic of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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