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RECRUITING
NCT05776056
PHASE4

Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Official title: Randomized Placebo-Controlled Trial of Methylphenidate for the Treatment of Post-Traumatic Stress Disorder With Associated Neurocognitive Complaints

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2024-02-05

Completion Date

2027-03-31

Last Updated

2026-01-09

Healthy Volunteers

No

Interventions

DRUG

Methylphenidate

Methylphenidate 10mg will be taken twice daily.

DRUG

Placebo

An inactive pill (placebo) will be taken twice daily.

Locations (3)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, United States

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States