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

January 8, 2008 updated by: University of Pittsburgh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Western Psychiatric Institute and Clinic of UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Rohan Ganguli, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 15, 2008

Last Update Submitted That Met QC Criteria

January 8, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0312010
  • PITT#02 90599

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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