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

May 23, 2017 updated by: Herbert Meltzer, Northwestern University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

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
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt Psychiatric Hospital

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

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
aripiprazole (Abilify)
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.
Active Comparator: 2
ziprasidone (Geodon)
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
triglyceride/HDL ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder.
Time Frame: twelve months
twelve months

Collaborators and Investigators

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

Sponsor

Northwestern University

Collaborators

National Alliance for Research on Schizophrenia and Depression

Investigators

  • Principal Investigator: Tianlai Tang, M.D., Vanderbilt University Medical Center

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

January 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

February 6, 2006

First Submitted That Met QC Criteria

February 6, 2006

First Posted (Estimate)

February 7, 2006

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 050943
  • NARSAD

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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