Changes in Heart Rhythms Associated With Antipsychotic Drug Treatment

January 23, 2009 updated by: Vanderbilt University

Evaluating the Risks of Arrhythmia and Sudden Death Associated With Antipsychotic Drugs by Assessing the T Wave Abnormalities in the Holter Electrocardiogram

This study is being done to look at the electrical activity of the heart. This study will help decide whether taking recordings for a 24-hour period gives more useful information than recording it for a few seconds in a doctor's office. The study will compare 24 hour electrocardiogram (ECG) results of patients taking thioridazine (Mellaril) to those of other patients taking different medications that took part in another study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of the study is to assess the Tpe and QTc measures in 24 hr Holter echocardiograms in patients treated with atypical antipsychotic drgs (APDs). The primary comparisons of interest are olanzapine (no QTc prolongation) to ziprasidone (QTc prolongation) and thioridazine (QTc prolongation) as well as ziprasidone (possibly low TdP risk) to thioridazine (TdP risk). Secondary comparisons will be among all APDs available. In a previously approved study, conventional 24 hr Holter electrocardiograms were recorded from a total of 78 subjects during the course of treatment with psychotropic medications and without medication (in the case of normals and unmedicated patients). These recordings will be analyzed to yield Tpe, QTc and heart rate, and other measures. Data from additional patients is needed, therefore this study will include only patients currently treated with Mellaril (thioridazine), Risperdal (risperidone) and Seroquel (quetiapine).

Study Type

Observational

Enrollment (Anticipated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212-8645
        • Vanderbilt Psychiatric Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults diagnosed wtih schizophrenia, bipolar or schizoaffective disorder

Description

Inclusion Criteria:

  • Patients must be male or female, age 18-65

    • Patients must have a definitive diagnosis by DSM-IV criteria of schizophrenia, bipolar or schizoaffective disorder.
    • Patients can be receiving inpatient or outpatient treatment at time of enrollment.
    • Patients must have been treated with (Mellaril) thioridazine, (Risperdal) risperidone or (Seroquel) quetiapine at least three months at time of enrollment.
    • Patients must be able to provide written informed consent

Exclusion Criteria:

  • Patients with a primary diagnosis other than schizophrenia, schizoaffective or bipolar disorder

    • Patients who are currently taking other medications that have been shown to prolong the QTC, including tricyclic antidepressants, fluoroquinolones or antiarrythmics.
    • Patients unable to provide written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Thioridazine Group
Patients must have been treated with (Mellaril) thioridazine at least three months at time of enrollment.
Device: 24 Holter Monitor Recording

All subjects will be fitted with a device to obtain 24-hour Holter EKG continuous recordings of bipolar leads C5C5R. They will also receive a standard 12-lead EKG recording prior to the placement of the Holter device. The subjects will be asked to keep a diary during the course of the 24 hours to record information such as wake and sleep times and symptoms such as shortness of breath, heart palpitations, lightheadedness, etc.

From each recording, 12 sets of 10 consecutive QRS epochs, plus QRS samplings obtained during sleep will be analyzed by a cardiologist blind to the medication status of subjects.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

Eli Lilly and Company

Investigators

  • Principal Investigator: Herbert Meltzer, M.D., Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

October 1, 2007

First Submitted That Met QC Criteria

October 1, 2007

First Posted (Estimate)

October 2, 2007

Study Record Updates

Last Update Posted (Estimate)

January 27, 2009

Last Update Submitted That Met QC Criteria

January 23, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 070591

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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