Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid Measures and Ischemic Electrocardiographic Changes

Schizophrenia Clinical Trial

Official title:

Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid Measures and Ischemic Electrocardiographic Changes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00288353
• Other study ID #: 050943
• Secondary ID: NARSAD
• Status: Terminated
• Phase: Phase 3
• First received: February 6, 2006
• Last updated: May 23, 2017
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: May 2017
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary goal of this study is to examine the triglyceride/HDL ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder.

Description:

The primary goal of this study is to examine the triglyceride/HDL ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder. The secondary goal is to identify those subjects in the top tertile for the highest risk of IHD as defined by TG/HDL ratios (>>3.5) and ischemic EKG changes with and without clinical ischemia, e.g. angina and to see if these risk factors can be reduced or reversed by a change of antipsychotic medication, dietary counseling, enrollment into available exercise groups, etc.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria

To be eligible, a patient must :

• Be male or female, between 18-65.

• Have a diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-IV criteria

• Have TG/HDL ratios (>>3.5) and ischemic EKG changes with and without clinical ischemia, e.g. angina

• Be treated for a minimum of six months with one of six oral antipsychotic medications: clozapine, haloperidol, olanzapine, quetiapine, risperidone and ziprasidone

• Be willing to change current antipsychotic medication to that chosen by the principal investigator

• Have a history of compliance with the above medication

• Be Medicaid eligible or maintain insurance covering requested lab procedures

• Be able to provide written informed consent.

Exclusion criteria

A patient will be considered ineligible if he/she:

• Has a diagnosis other than schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to DSM-IV criteria.

• Has a history of noncompliance with prescribed psychiatric medications

• Has a TG/HDL ratio < 3.5 on current medication

• Is uninsured or is unable to self-pay potential costs of required lab procedures not covered by insurance.

• Is unable to provide written informed consent.

• (Females only) Is pregnant, lactating or plans to become pregnant during study participation

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• aripiprazole (Abilify)
active drug given daily as per package insert according to standard clinical care for twelve month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication.
• ziprasidone (Geodon)
active medication will be given daily as per package insert according to standard clinical care for the twelve month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication.

Locations

Country	Name	City	State
United States	Vanderbilt Psychiatric Hospital	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	triglyceride/HDL ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder.		twelve months