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

Primary Purpose

Overweight, Hyperlipidemia, Cardiovascular Diseases

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Schizophrenia, Schizoaffective disorder, Aripiprazole, Obese, Overweight, Heart Health, Antipsychotic, Heart Health Factors, Cardiovascular Health Indices, Cardiovascular health

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Western Psychiatric Institute and Clinic of UPMC

Outcomes

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

Full Information

First Posted
September 7, 2005
Last Updated
January 8, 2008
Sponsor
University of Pittsburgh
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00222833
Brief Title
The Effect of Switching to Aripiprazole on Heart Health in Overweight and Obese Patients With Schizophrenia
Official Title
The Effect of Switching to Aripiprazole on Indices of Cardiovascular Health in Overweight and Obese Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh
Collaborators
Bristol-Myers Squibb

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Hyperlipidemia, Cardiovascular Diseases
Keywords
Schizophrenia, Schizoaffective disorder, Aripiprazole, Obese, Overweight, Heart Health, Antipsychotic, Heart Health Factors, Cardiovascular Health Indices, Cardiovascular health

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Primary Outcome Measure Information:
Title
To examine heart health factors: serum lipids, serum leptin, fasting blood glucose, body weight, and blood pressure
Secondary Outcome Measure Information:
Title
Changes in clinical state
Title
Pre-existing or emergent side effects
Title
Cognition and insight
Title
Attitude towards medication
Title
Social functioning
Title
Quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rohan Ganguli, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Institute and Clinic of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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

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