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NCT06188923 · ClinicalTrials.gov registry record · Phase 2
A New Intervention to Improve Function in Veterans With Anxiety and Depression
A Phase 2 study of Anxiety and Depression, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT06188923: Recruiting Phase 2 study of Anxiety and Depression, sponsored by VA Office of Research and Development.
NCT06188923 is a Phase 2 study of Anxiety and Depression that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06188923, a Phase 2 study of Anxiety and Depression, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
Study Summary
Anxiety and depression symptoms occur at high rates in Veteran populations and can significantly impact function, compromising the ability to work and to successfully form and maintain valued relationships. Several other symptoms commonly occur with anxiety and depression, including poor sleep quality and chronic pain. Since all these symptoms frequently occur together, they may have a common underlying biological basis. A single medication that could effectively treat all these symptoms would be ideal. Converging data suggest that pregnenolone is a promising pharmacological agent for treating multiple psychiatric symptoms and functional impairment. The investigators thus propose to conduct a clinical trial of pregnenolone in Veterans with anxiety and depression symptoms. Pregnenolone has minimal side effects, and the prior research demonstrates that pregnenolone is well-tolerated by Veterans. Treatment with pregnenolone could thus be an efficacious new therapeutic for Veterans experiencing depression, anxiety, poor sleep quality and chronic pain conditions.
Primary Outcome
The WHODAS-II is an instrument developed by the World Health Organization to assess behavioral limitations and restrictions regarding participation in specific activity domains experienced by an individual independent of their medical diagnosis. The conceptual frame of reference of this instrument is the International Classification of Functioning, Disability, and Health (ICF). Specifically, the instrument is a 36-item, generic, multidimensional questionnaire designed to evaluate the functioning
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pregnenolone
Study Locations (1)
North Carolina
- Durham VA Medical Center, Durham, NC - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2025-08-14 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 2 |
What NCT06188923 shows while recruiting
NCT06188923 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Anxiety and Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06188923 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06188923 about?
NCT06188923 is a clinical study titled "A New Intervention to Improve Function in Veterans With Anxiety and Depression". Anxiety and depression symptoms occur at high rates in Veteran populations and can significantly impact function, compromising the ability to work and to successfully form and maintain valued relationships. Several other symptoms commonly occur with anxiety and depression, including poor sleep quali...
What is the current status of trial NCT06188923?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2025-08-14. Estimated completion is 2028-09-30.
What conditions does trial NCT06188923 study?
This clinical trial studies the following conditions: Anxiety and Depression.
What interventions are being tested in trial NCT06188923?
The interventions under investigation include: Placebo (DRUG), Pregnenolone (DRUG).
Who is sponsoring clinical trial NCT06188923?
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 NCT06188923 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06188923's enrollment target sits among peer trials
84 822nd of 2000 higher than 1,174 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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