Changes in Heart Rhythms Associated With Antipsychotic Drug Treatment

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00538122
First received: October 1, 2007
Last updated: January 23, 2009
Last verified: January 2009
  Purpose

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 Intervention
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Device: 24 Holter Monitor Recording

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Estimated Enrollment: 12
Study Start Date: July 2007
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults diagnosed wtih schizophrenia, bipolar or schizoaffective disorder

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538122

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

No publications provided

Responsible Party: Herbert Meltzer, M.D., Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00538122     History of Changes
Other Study ID Numbers: 070591
Study First Received: October 1, 2007
Last Updated: January 23, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Thioridazine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014