Changes in Heart Rhythms Associated With Antipsychotic Drug Treatment
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|ClinicalTrials.gov Identifier: NCT00538122|
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : January 27, 2009
|Condition or disease||Intervention/treatment|
|Schizophrenia Schizoaffective Disorder Bipolar Disorder||Device: 24 Holter Monitor Recording|
|Study Type :||Observational|
|Estimated Enrollment :||12 participants|
|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|
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.
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 ClinicalTrials.gov identifier (NCT number): NCT00538122
|United States, Tennessee|
|Vanderbilt Psychiatric Hospital|
|Nashville, Tennessee, United States, 37212-8645|
|Principal Investigator:||Herbert Meltzer, M.D.||Vanderbilt University Medical Center|