Changes in Heart Rhythms Associated With Antipsychotic Drug Treatment
Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
Intervention: 24 Holter Monitor Recording (Device)
Phase: N/A
Status: Completed
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s): Herbert Meltzer, M.D., Principal Investigator, Affiliation: Vanderbilt University
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.
Clinical Details
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 design: Time Perspective: Prospective
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Vanderbilt Psychiatric Hospital, Nashville, Tennessee 37212-8645, United States
Additional Information
Starting date: July 2007
Last updated: January 23, 2009
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