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NCT03491007 · ClinicalTrials.gov registry record · Phase 2
Neurosteroids in PTSD - Biomarkers to Therapeutics
A Phase 2 study, sponsored by VA Office of Research and Development.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT03491007: Clinical Trial Phase 2 study, sponsored by VA Office of Research and Development.
NCT03491007 is a Phase 2 study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03491007, a Phase 2 study, was terminated before completion, sponsored by VA Office of Research and Development.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
The purpose of this research is to determine if a study medication called Dehydroepiandrosterone (DHEA) helps to reduce PTSD symptoms in OEF/OIF/OND Veterans. In addition to finding out if DHEA is effective for treating PTSD symptoms, this research seeks to determine if DHEA is effective in treating other symptoms, such as depression and anxiety. Depression and anxiety are symptoms that are frequently present in Veterans who are experiencing PTSD. Another purpose of this research is to takes pictures of the brain using magnetic resonance imaging (MRI) and blood levels of various small molecules including neurosteroids and also proteins, which may be affected by the study drug and/or related to symptoms in Veterans with PTSD. This study seeks to determine if DHEA is changed to other compounds after it is taken by mouth and the safety and effectiveness of DHEA in Veterans with PTSD. This is an "add-on" study and Veterans enrolled in the study will continue to take all of their current medications without any changes (also called "usual care"), and DHEA or a sugar pill (also called a "placebo") will then be added to their current medication regimen.
Primary Outcome
The Shifted-Attention Emotion Appraisal (SEAT) Paradigm will present compound stimuli that include both emotional faces (e.g. sad, happy, angry) and neutral scenes. In three different conditions, participants are asked to respond to three different questions: (1) 'Gender'; (2) 'Inside/Outside'; or (3) 'Like/Dislike'. This allows multiple components of cognition to be probed including (1) implicit emotional processing, (2) attentional modulation, and (3) cognitive modulation of emotion. Item-spec
Interventions
- DRUG DHEA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-07-08 |
| Est. Completion | 2020-11-16 |
| Phase | Phase 2 |
Why NCT03491007 stopped before completion
NCT03491007 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which DHEA is the first listed.
NCT03491007 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03491007 about?
NCT03491007 is a clinical study titled "Neurosteroids in PTSD - Biomarkers to Therapeutics". The purpose of this research is to determine if a study medication called Dehydroepiandrosterone (DHEA) helps to reduce PTSD symptoms in OEF/OIF/OND Veterans. In addition to finding out if DHEA is effective for treating PTSD symptoms, this research seeks to determine if DHEA is effective in treating...
What is the current status of trial NCT03491007?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2019-07-08. Estimated completion is 2020-11-16.
What interventions are being tested in trial NCT03491007?
The interventions under investigation include: DHEA (DRUG).
Who is sponsoring clinical trial NCT03491007?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03491007's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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