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Changes in Heart Rhythms Associated With Antipsychotic Drug Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00538122
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : January 27, 2009
Eli Lilly and Company
Information provided by:
Vanderbilt University

Brief Summary:
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.

Condition or disease Intervention/treatment
Schizophrenia Schizoaffective Disorder Bipolar Disorder Device: 24 Holter Monitor Recording

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
Estimated Enrollment : 12 participants
Time Perspective: Prospective
Official Title: Evaluating the Risks of Arrhythmia and Sudden Death Associated With Antipsychotic Drugs by Assessing the T Wave Abnormalities in the Holter Electrocardiogram
Study Start Date : July 2007
Primary Completion Date : July 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults diagnosed wtih schizophrenia, bipolar or schizoaffective disorder

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.

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 identifier (NCT number): NCT00538122

United States, Tennessee
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, United States, 37212-8645
Sponsors and Collaborators
Vanderbilt University
Eli Lilly and Company
Principal Investigator: Herbert Meltzer, M.D. Vanderbilt University Medical Center

Responsible Party: Herbert Meltzer, M.D., Vanderbilt University Medical Center Identifier: NCT00538122     History of Changes
Other Study ID Numbers: 070591
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: January 27, 2009
Last Verified: January 2009

Keywords provided by Vanderbilt University:
schizoaffective disorder
bipolar disorder
antipsychotic drug treatment

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