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

NCT00288353 | Terminated Phase 3 Results

• 2 other identifiers: 050943NARSAD
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Keywords

schizophrenia; schizoaffective disorder; bipolar disorder; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Triglyceride/High-density Lipoprotein (TG/HDL) Ratio

  24 weeks

Secondary Outcomes (5)

• Weight

  24 weeks

• Body Mass Index (BMI)

  24 weeks

• Cholesterol

  24 weeks

• High-Density Lipoprotein (HDL)

  24 weeks

• Triglyceride (TG)

  24 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

aripiprazole (Abilify)

Drug: aripiprazole (Abilify)

2

ACTIVE COMPARATOR

ziprasidone (Geodon)

Drug: ziprasidone (Geodon)

Interventions

aripiprazole (Abilify) DRUG

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.

1

ziprasidone (Geodon) DRUG

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.

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Vanderbilt Psychiatric Hospital

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Metabolic Syndrome

Interventions

Aripiprazole; ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Herbert Meltzer
• Organization: Northwestern University

h-meltzer@northwestern.edu

(312) 503-0309

Study Officials

• Tianlai Tang, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: January 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 2, 2025
• Results First Posted: October 2, 2025

Record last verified: 2025-09

Locations

US (1)