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NCT03765138 · ClinicalTrials.gov registry record · Phase 3
Combined Treatment of Prolonged Exposure and Pramipexole for Posttraumatic Stress Disorder and Depression
A Phase 3 study, sponsored by Research Foundation for Mental Hygiene.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
NCT03765138: Clinical Trial Phase 3 study, sponsored by Research Foundation for Mental Hygiene.
NCT03765138 is a Phase 3 study that was terminated before completion, run by Research Foundation for Mental Hygiene. The registered enrollment target is 1 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03765138, a Phase 3 study, was terminated before completion, sponsored by Research Foundation for Mental Hygiene.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
Study Summary
This pilot study aims to test the safety, feasibility, and initial efficacy of combined 10 week treatment of prolonged exposure (PE) and Pramipexole in patients with comorbid posttraumatic stress disorder (PTSD) and depression (MDD). Resting state functional connectivity (rsFC) will be assessed at baseline and en of treatment.
Primary Outcome
The CAPS is the gold standard in PTSD assessment. It is a 30-item structured interview used for current (past week or month) and lifetime diagnosis of PTSD. The CAPS was designed to be administered by clinicians and clinical researchers who have a working knowledge of PTSD. The full interview takes 45-60 minutes to administer. Scores range from 0 to 80 with higher values represent a worse outcome.
Interventions
- COMBINATION_PRODUCT PE/Pramipexole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-02-19 |
| Est. Completion | 2019-08-26 |
| Phase | Phase 3 |
Why NCT03765138 stopped before completion
NCT03765138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which PE/Pramipexole is the first listed.
NCT03765138 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03765138 about?
NCT03765138 is a clinical study titled "Combined Treatment of Prolonged Exposure and Pramipexole for Posttraumatic Stress Disorder and Depression". This pilot study aims to test the safety, feasibility, and initial efficacy of combined 10 week treatment of prolonged exposure (PE) and Pramipexole in patients with comorbid posttraumatic stress disorder (PTSD) and depression (MDD). Resting state functional connectivity (rsFC) will be assessed at b...
What is the current status of trial NCT03765138?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2019-02-19. Estimated completion is 2019-08-26.
What interventions are being tested in trial NCT03765138?
The interventions under investigation include: PE/Pramipexole (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03765138?
This trial is sponsored by Research Foundation for Mental Hygiene, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03765138's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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