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NCT00046553 · ClinicalTrials.gov registry record
Brain Receptor Function in Post-Traumatic Stress Disorder
A clinical trial, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- 97
- Enrollment target
NCT00046553 is a clinical trial that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 97 participants.
The verdict
NCT00046553 has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- 97 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the function of cortisol receptors in post-traumatic stress disorder (PTSD). Patients with PTSD have neurobiological dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis function. High corticotrophin releasing hormone (CRH) levels and decreased hippocampal volume are major features of the disorder. The mechanisms responsible for these alterations are not known. This study will evaluate the function of cortisol receptors to determine their roles in maintaining PTSD HPA axis dysregulation. Three groups of subjects will take part in the study: Patients with PTSD, healthy control subjects who were exposed to trauma in the past and remained healthy and healthy control subjects who were never traumatized At study entry, the cerebral spinal fluid (CSF) of all participants will be sampled and evaluated. Participants will also undergo a magnetic resonance imaging (MRI) scan of the brain as well as eye blink trace conditioning and neuropsychological tests. Participants will be admitted to the Clinical Center for two nights on three different occasions. At each overnight visits, blood levels of stress hormones will be measured every hour for 26 hours after medication or placebo are given. This will be the end of the study for both groups of healthy control subjects, with the exception that they may be asked to repeat neuropsychologic and eye blink tests after 12 weeks. Participants with PTSD will receive paroxetine for 10 weeks. After 10 weeks these participants will be reevaluated in exactly the same way as before treatment (except they will not repeat the MRI scan).
Interventions
- DRUG RU-486 (Mifepristone)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2002-09 |
| Est. Completion | 2004-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00046553
The ClinicalTrials.gov registry entry for NCT00046553 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 97 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 1 intervention - of which RU-486 (Mifepristone) is the first listed.
NCT00046553 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00046553 about?
NCT00046553 is a clinical study titled "Brain Receptor Function in Post-Traumatic Stress Disorder". The purpose of this study is to examine the function of cortisol receptors in post-traumatic stress disorder (PTSD). Patients with PTSD have neurobiological dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis function. High corticotrophin releasing hormone (CRH) levels and decreased hipp...
What is the current status of trial NCT00046553?
This trial is currently completed. The enrollment target is 97 participants. The study started on 2002-09. Estimated completion is 2004-10.
What interventions are being tested in trial NCT00046553?
The interventions under investigation include: RU-486 (Mifepristone) (DRUG).
Who is sponsoring clinical trial NCT00046553?
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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