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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
aripiprazole (Abilify)
ziprasidone (Geodon)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, schizoaffective disorder, bipolar disorder, metabolic syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt Psychiatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

aripiprazole (Abilify)

ziprasidone (Geodon)

Outcomes

Primary Outcome Measures

triglyceride/HDL ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2006
Last Updated
May 23, 2017
Sponsor
Northwestern University
Collaborators
National Alliance for Research on Schizophrenia and Depression
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1. Study Identification

Unique Protocol Identification Number
NCT00288353
Brief Title
Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid Measures and Ischemic Electrocardiographic Changes
Official Title
Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid Measures and Ischemic Electrocardiographic Changes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
unable to secure additional funding
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
Keywords
schizophrenia, schizoaffective disorder, bipolar disorder, metabolic syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
aripiprazole (Abilify)
Arm Title
2
Arm Type
Active Comparator
Arm Description
ziprasidone (Geodon)
Intervention Type
Drug
Intervention Name(s)
aripiprazole (Abilify)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
ziprasidone (Geodon)
Intervention Description
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.
Primary Outcome Measure Information:
Title
triglyceride/HDL ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder.
Time Frame
twelve months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tianlai Tang, M.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt Psychiatric Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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