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

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ClinicalTrials.gov Identifier: NCT00288353
Recruitment Status : Terminated (unable to secure additional funding)
First Posted : February 7, 2006
Last Update Posted : May 25, 2017
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Herbert Meltzer, Vanderbilt University

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 Type : Interventional  (Clinical Trial)
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 : January 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


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.




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


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288353


Locations
United States, Tennessee
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Northwestern University
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Tianlai Tang, M.D. Vanderbilt University Medical Center

Responsible Party: Herbert Meltzer, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00288353     History of Changes
Other Study ID Numbers: 050943
NARSAD
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017

Keywords provided by Herbert Meltzer, Vanderbilt University:
schizophrenia
schizoaffective disorder
bipolar disorder
metabolic syndrome

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Aripiprazole
Ziprasidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents