RecruitingPhase 4NCT05776056

Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints

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

Sponsor

VA Office of Research and Development

Enrollment

70 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

Posttraumatic Stress Disorder (PTSD)

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether methylphenidate (the active ingredient in Ritalin, commonly used for ADHD) can help military veterans with PTSD who also have cognitive complaints — like difficulty concentrating, memory problems, and mental fog. Researchers believe that treating these cognitive symptoms may also improve overall PTSD outcomes. **You may be eligible if...** - You are a US military veteran between 18 and 65 years old - You have a confirmed PTSD diagnosis (based on standard clinical interviews) - Your PTSD symptoms are moderate to severe (CAPS-5 score of 26 or higher) - You report significant cognitive difficulties on a self-reported questionnaire **You may NOT be eligible if...** - You have bipolar I disorder, schizophrenia, or certain other psychiatric conditions - You have a history of heart problems or uncontrolled high blood pressure (stimulants can affect heart rate) - You are currently taking certain medications that interact with methylphenidate - You have active substance use problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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