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

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

Study Overview

• Status: Terminated
• Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
• Intervention / Treatment: Drug: aripiprazole (Abilify); Drug: ziprasidone (Geodon)

Detailed Description

The primary goal of this study is to examine the triglyceride/high-density lipoprotein (TG/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 ischemic heart disease (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): 48
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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 Diagnostic and Statistical Manual (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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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/High-density Lipoprotein (TG/HDL) Ratio	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Weight	24 weeks
Body Mass Index (BMI)	24 weeks
Cholesterol	24 weeks
High-Density Lipoprotein (HDL)	24 weeks
Triglyceride (TG)	24 weeks

Collaborators and Investigators

• 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

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 (Estimated): February 7, 2006

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: schizophrenia; schizoaffective disorder; bipolar disorder; metabolic syndrome
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Metabolic Diseases; Glucose Metabolism Disorders; Mood Disorders; Insulin Resistance; Hyperinsulinism; Nutritional and Metabolic Diseases; Schizophrenia; Psychotic Disorders; Bipolar Disorder; Metabolic Syndrome; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinolones; Quinolines; Piperazines; Aripiprazole; ziprasidone
• Other Study ID Numbers: 050943; NARSAD