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

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT00222833

Collaborator

Bristol-Myers Squibb (Industry)

Enrollment

Location

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Overweight Hyperlipidemia Cardiovascular Diseases	Drug: Aripiprazole	Phase 4

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 patients with Schizophrenia or Schizoaffective disorder. Thirty partially remitted patients with Positive and Negative Syndrome Scale (PANSS) score of less than 100, who have body mass index (BMI) of 26 or higher will be switched from their existing antipsychotic to aripiprazole over 2-3 weeks period using a clinician determined cross-tapering approach.The objective of the study is to examine cardiovascular health indices 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 clinical state, preexisting or emergent side-effects, how brain processes information and changes in social functioning and quality of life.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

To examine heart health factors: serum lipids, serum leptin, fasting blood glucose, body weight, and blood pressure []

Secondary Outcome Measures

Changes in clinical state []
Pre-existing or emergent side effects []
Cognition and insight []
Attitude towards medication []
Social functioning []
Quality of life []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.