Changes in Heart Rhythms Associated With Antipsychotic Drug Treatment
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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 |
| 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 |
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.
Contacts and Locations| United States, Tennessee | |
| Vanderbilt Psychiatric Hospital | |
| Nashville, Tennessee, United States, 37212-8645 | |
| 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 May 19, 2013