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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 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 111-participant average among 17 other Posttraumatic Stress Disorder (PTSD) trials with a reported enrollment target (37% lower). The trial reports 3 study locations across 2 states.

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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.

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

FieldValue
Enrollment Target 70 participants
Start Date 2024-02-05
Est. Completion 2027-03-31
Phase Phase 4

Sponsor

VA Office of Research and Development

1,668 total trials

What the Registry Record Tells You About NCT05776056

The ClinicalTrials.gov registry entry for NCT05776056 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 111-participant average among 17 other Posttraumatic Stress Disorder (PTSD) trials with a reported enrollment target (37% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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