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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222833
• Other study ID #: 0312010
• Secondary ID: PITT#02 90599
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: January 8, 2008
• Start date: October 2004
• Est. completion date: December 2005

Study information

• Verified date: January 2008
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hyperlipidemia
• Hyperlipidemias
• Overweight
• Schizophrenia

Intervention

Drug:
• Aripiprazole

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Clinic of UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine heart health factors: serum lipids, serum leptin, fasting blood glucose, body weight, and blood pressure
Secondary	Changes in clinical state
Secondary	Pre-existing or emergent side effects
Secondary	Cognition and insight
Secondary	Attitude towards medication
Secondary	Social functioning
Secondary	Quality of life