Changes in Heart Rhythms Associated With Antipsychotic Drug Treatment

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538122
• Other study ID #: 070591
• Status: Completed
• Phase: N/A
• First received: October 1, 2007
• Last updated: January 23, 2009
• Start date: July 2007
• Est. completion date: September 2008

Study information

• Verified date: January 2009
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt Psychiatric Hospital	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Eli Lilly and Company

Country where clinical trial is conducted

United States,