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NCT01739335 · ClinicalTrials.gov registry record · Phase 2
Novel Therapeutics in Posttraumatic Stress Disorder (PTSD): A Randomized Clinical Trial of Mifepristone
A Phase 2 study of Stress Disorders, Post-Traumatic, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 5
- Study locations
NCT01739335 is a Phase 2 study of Stress Disorders, Post-Traumatic that has completed, run by VA Office of Research and Development. The registered enrollment target is 81 participants, below the 154-participant average among 64 other Stress Disorders, Post-Traumatic trials with a reported enrollment target (47% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT01739335, a Phase 2 study of Stress Disorders, Post-Traumatic, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
- 5
- Study locations
Study Summary
Posttraumatic stress disorder (PTSD) is a common and disabling psychiatric disorder for Veterans. Left untreated or under-treated, it can become a chronic condition associated with significant distress, depression, aggression, family disruption, substance abuse and an increased risk of morbidity and mortality. Considerable advances were made in the treatment of PTSD in recent years; however, psychopharmacological treatments have been shown to be largely ineffective for Veterans with PTSD. To address this gap, this proposal seeks to test an innovative treatment approach in PTSD - pharmacological manipulation of the body's major stress system (the hypothalamic-pituitary-adrenal (HPA) axis) with mifepristone. At high doses mifepristone is a glucocorticoid receptor (GR) antagonist with peripheral and central nervous system effects, making it a compound of interest in the treatment of stress related disorders. There is abundant evidence of enhanced GR sensitivity in Veterans with PTSD which is thought to underlie some of the symptoms of PTSD and associated disturbances in mood and cognition. There is also evidence that short-term mifepristone treatment has sustained beneficial effects on mood, cognition and sleep disturbance in some neuropsychiatric conditions (major depression, bipolar disorder, primary insomnia). The purpose of the study is to examine the effects of mifepristone to determine if it is efficacious in improving PTSD symptoms and associated clinical outcomes. To achieve these objectives, the investigators propose to conduct a Phase IIa, multi-site, double-blind, placebo controlled trial of mifepristone in male Veteran outpatients with chronic PTSD through the VA's Cooperative Clinical Trial Award program. The investigators propose to enroll 90 subjects at multiple VA sites based on an estimated attrition rate of 20%. Eligible Veterans will be randomly assigned to the treatment of mifepristone (600 mg/day) or placebo for one week and followed for up to th
Conditions Studied
Interventions
- DRUG Placebo Oral Tablet
- DRUG Mifepristone Oral Tablet [Korlym]
Study Locations (5)
North Carolina
- Durham VA Medical Center - Durham
- Salisbury W.G. (Bill) Hefner VA Medical Center - Salisbury
California
- VA San Diego Healthcare System - San Diego
New Mexico
- Albuquerque VA Medical Center - Albuquerque
New York
- James J. Peters VA Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2012-11-19 |
| Est. Completion | 2016-11-16 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01739335
The ClinicalTrials.gov registry entry for NCT01739335 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 154-participant average among 64 other Stress Disorders, Post-Traumatic trials with a reported enrollment target (47% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stress Disorders, Post-Traumatic appearing as the primary indexed condition, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT01739335 reports 5 study locations spanning 4 distinct geographic areas - top geographies include North Carolina, California, New Mexico.
Frequently Asked Questions
What is clinical trial NCT01739335 about?
NCT01739335 is a clinical study titled "Novel Therapeutics in Posttraumatic Stress Disorder (PTSD): A Randomized Clinical Trial of Mifepristone". Posttraumatic stress disorder (PTSD) is a common and disabling psychiatric disorder for Veterans. Left untreated or under-treated, it can become a chronic condition associated with significant distress, depression, aggression, family disruption, substance abuse and an increased risk of morbidity and...
What is the current status of trial NCT01739335?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2012-11-19. Estimated completion is 2016-11-16.
What conditions does trial NCT01739335 study?
This clinical trial studies the following conditions: Stress Disorders, Post-Traumatic.
What interventions are being tested in trial NCT01739335?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Mifepristone Oral Tablet [Korlym] (DRUG).
Who is sponsoring clinical trial NCT01739335?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01739335 being conducted?
This trial has 5 study locations across California, New Mexico, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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