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| Sponsors and Collaborators: |
Vanderbilt University Eli Lilly and Company |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00538122 |
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: | 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 |
| Estimated Study Completion Date: | July 2008 |
| Estimated 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. |
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
Exclusion Criteria:
Patients with a primary diagnosis other than schizophrenia, schizoaffective or bipolar disorder
Contacts and Locations| United States, Tennessee | |
| Vanderbilt Psychiatric Hospital | |
| Nashville, Tennessee, United States, 37212-8645 | |
| Principal Investigator: | Herbert Meltzer, M.D. | Vanderbilt University |
| Principal Investigator: | Herbert Meltzer, M.D. | Vanderbilt University |
More Information
| Responsible Party: | Vanderbilt University Medical Center ( Herbert Meltzer, M.D. ) |
| Study ID Numbers: | 070591 |
| Study First Received: | October 1, 2007 |
| Last Updated: | September 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00538122 |
| Health Authority: | United States: Institutional Review Board |
|
schizophrenia schizoaffective disorder bipolar disorder |
antipsychotic drug treatment safety arrythmias |
|
Schizophrenia Affective Disorders, Psychotic Death Mental Disorders Bipolar Disorder Death, Sudden |
Mood Disorders Psychotic Disorders Congenital Abnormalities Schizophrenia and Disorders with Psychotic Features Arrhythmias, Cardiac |
|
Pathologic Processes Disease |
