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

Sponsor

Northwestern University (Other)

Overall Status

Terminated

CT.gov ID

NCT00288353

Collaborator

National Alliance for Research on Schizophrenia and Depression (Other)

250

Enrollment

Location

Arms

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizoaffective Disorder Bipolar Disorder	Drug: aripiprazole (Abilify) Drug: ziprasidone (Geodon)	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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