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NCT00069225 · ClinicalTrials.gov registry record
Brain Structure and Function Before and After Treatment for Post-Traumatic Stress Disorder
A clinical trial, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- 95
- Enrollment target
NCT00069225 is a clinical trial that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 95 participants.
The verdict
NCT00069225 has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- 95 participants
- Enrollment target
Study Summary
This study, conducted at the University of Pennsylvania and at the National Institutes of Health in Bethesda, Maryland, will examine deficits in brain structure and function in people exposed to trauma who developed post-traumatic stress disorder (PTSD) to see if these deficits change after treatment. It also will investigate whether there is a genetic susceptibility to PTSD. Candidates 18 years of age and older in the following categories will be included in this study: 1) women who have PTSD of at least 1 year's duration following sexual or non-sexual assault; 2) healthy women (controls) who were previously assaulted but did not develop PTSD; and 3) healthy women (controls) who were never traumatized. Candidates will be screened with a medical history and physical examination, psychiatric evaluation, electrocardiogram (EKG), and routine blood and urine tests. Women with PTSD will be assigned to receive either: 1) 12 weeks of cognitive behavioral psychotherapy either immediately upon enrollment or after a 3-month waiting period; or 2) 10 weeks of drug treatment with paroxetine (Paxil® (Registered Trademark)). Patients will be evaluated before and after treatment with the procedures outlined below. Control subjects will undergo the same procedures, also with a 10- to 12-week interval between evaluations. * Neuropsychological testing: Subjects will take paper and pencil and computer tests to evaluate memory, learning, attention and concentration, vocabulary and naming. * Magnetic resonance imaging (MRI): Subjects will have MRI scans of the brain to examine brain structure and blood flow while they perform two tasks. In the first task, they will be shown a series of faces and asked to press one button for a male face and another button for a female face. In the second task they will hear loud noises and see colored squares. During the scan, subjects lie on a bed that slides into a narrow tunnel (the scanner). They will wear a headset to block the noise of the scann
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2003-09 |
| Est. Completion | 2005-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00069225
The ClinicalTrials.gov registry entry for NCT00069225 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00069225 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00069225 about?
NCT00069225 is a clinical study titled "Brain Structure and Function Before and After Treatment for Post-Traumatic Stress Disorder". This study, conducted at the University of Pennsylvania and at the National Institutes of Health in Bethesda, Maryland, will examine deficits in brain structure and function in people exposed to trauma who developed post-traumatic stress disorder (PTSD) to see if these deficits change after treatmen...
What is the current status of trial NCT00069225?
This trial is currently completed. The enrollment target is 95 participants. The study started on 2003-09. Estimated completion is 2005-09.
Who is sponsoring clinical trial NCT00069225?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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