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NCT04885257 · ClinicalTrials.gov registry record · Phase 1
Methylphenidate for Ptsd and Stroke Veterans
A Phase 1 study of Stroke and PTSD, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04885257: Completed Phase 1 study of Stroke and PTSD, sponsored by VA Office of Research and Development.
NCT04885257 is a Phase 1 study of Stroke and PTSD that has completed, run by VA Office of Research and Development. The registered enrollment target is 20 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04885257, a Phase 1 study of Stroke and PTSD, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Veterans with post-traumatic stress disorder (PTSD) have an increased risk of developing ischemic stroke. Veterans enduring PTSD face difficulties in managing their PTSD severity after suffering from a stroke. Currently, clinical trials in PTSD exclude patients with stroke and patients with significant premorbid psychological conditions like PTSD are usually excluded from stroke clinical trials. Methylphenidate (MPH) is a central nervous system stimulant that can improve PTSD symptoms: avoidance behaviors, social withdrawal, hyperarousal, and working memory. MPH can also improve post-stroke outcomes: mood, activities of daily living, and motor functioning. In clinical trials for PTSD or stroke, MPH has been shown to be well-tolerated with minimal adverse events. The high prevalence of PTSD in Veterans with stroke provides strong justification for development of interventions that effectively and simultaneously target both conditions. The overarching goal of our proposal is to understand how MPH improves PTSD severity in Veterans with comorbid stroke.
Primary Outcome
The modified Ranking scale (mRS) is a single-item, global, Likert-type scale ranging from 0-6 (higher scores mean a worse outcome) to categorize level of functional independence with comparison to pre-stroke function, accounting for activities of daily living. Participants were scored at baseline, Week 4, Week 8, Week 12, and 30 days after tapering after methylphenidate/placebo. The mean change from baseline at Week 12 for each group is reported.
Interventions
- DRUG Placebo
- DRUG Methylphenidate
Study Locations (1)
Alabama
- Birmingham VA Medical Center, Birmingham, AL - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-01-14 |
| Est. Completion | 2025-05-05 |
| Phase | Phase 1 |
What the finished NCT04885257 record still lists
NCT04885257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04885257 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT04885257 about?
NCT04885257 is a clinical study titled "Methylphenidate for Ptsd and Stroke Veterans". Veterans with post-traumatic stress disorder (PTSD) have an increased risk of developing ischemic stroke. Veterans enduring PTSD face difficulties in managing their PTSD severity after suffering from a stroke. Currently, clinical trials in PTSD exclude patients with stroke and patients with signific...
What is the current status of trial NCT04885257?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2022-01-14. Estimated completion is 2025-05-05.
What conditions does trial NCT04885257 study?
This clinical trial studies the following conditions: Stroke, PTSD.
What interventions are being tested in trial NCT04885257?
The interventions under investigation include: Placebo (DRUG), Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT04885257?
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 NCT04885257 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04885257's enrollment target sits among peer trials
20 361st of 454 higher than 74 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke 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.
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