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NCT05776056 · ClinicalTrials.gov registry record · Phase 4
Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints
A Phase 4 study of Posttraumatic Stress Disorder (PTSD), sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
- 3
- Study locations
NCT05776056: Recruiting Phase 4 study of Posttraumatic Stress Disorder (PTSD), sponsored by VA Office of Research and Development.
NCT05776056 is a Phase 4 study of Posttraumatic Stress Disorder (PTSD) that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 70 participants, below the 109-participant average among 31 other Posttraumatic Stress Disorder (PTSD) trials with a reported enrollment target (36% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05776056, a Phase 4 study of Posttraumatic Stress Disorder (PTSD), is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
- 3
- Study locations
Study Summary
Posttraumatic stress disorder (PTSD) is frequently accompanied by difficulty concentrating, poor memory, and inability to keep up with tasks, which negatively impacts a person's ability to function at work and in relationships. Currently available treatments do not fully relieve all symptoms. A published research report showed positive evidence that the stimulant medication methylphenidate was beneficial in treating these problems. This study will evaluate the ability of methylphenidate to treat PTSD and associated neurocognitive complaints in Veterans. An innovative feature is the study's N-of-1 design. In this design, every participant will move back and forth every 4-5 weeks between treatment with methylphenidate and treatment with placebo, in random order and under double-blind conditions, over a 20-week period. The investigators will compare the aggregated change in PTSD and neurocognitive symptoms between periods of treatment with methylphenidate versus placebo. Results will help clinicians to better choose the best treatment for Veterans living with PTSD.
Primary Outcome
PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report that assesses how much the participant was bothered by each DSM-5 symptoms of PTSD with a rating of 0 "not at all" to 4 "extremely;" summed score ranges from 0-80 with higher score indicating more severe symptoms.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Methylphenidate
Study Locations (3)
Alabama
- Birmingham VA Medical Center, Birmingham, AL - Birmingham
- Tuscaloosa VA Medical Center, Tuscaloosa, AL - Tuscaloosa
Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2024-02-05 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 4 |
What NCT05776056 shows while recruiting
NCT05776056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 109-participant average among 31 other Posttraumatic Stress Disorder (PTSD) trials with a reported enrollment target (36% lower).
The record links to 1 condition, with Posttraumatic Stress Disorder (PTSD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05776056 reports a single indexed study location in Alabama, Washington.
Frequently Asked Questions
What is clinical trial NCT05776056 about?
NCT05776056 is a clinical study titled "Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints". Posttraumatic stress disorder (PTSD) is frequently accompanied by difficulty concentrating, poor memory, and inability to keep up with tasks, which negatively impacts a person's ability to function at work and in relationships. Currently available treatments do not fully relieve all symptoms. A publ...
What is the current status of trial NCT05776056?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2024-02-05. Estimated completion is 2027-03-31.
What conditions does trial NCT05776056 study?
This clinical trial studies the following conditions: Posttraumatic Stress Disorder (PTSD).
What interventions are being tested in trial NCT05776056?
The interventions under investigation include: Placebo (DRUG), Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT05776056?
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 NCT05776056 being conducted?
This trial has 3 study locations across Alabama, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05776056's enrollment target sits among peer trials
70 20th of 31 higher than 12 of 31 other Posttraumatic Stress Disorder (PTSD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Posttraumatic Stress Disorder (PTSD) 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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