Actively Recruiting
Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints
Led by VA Office of Research and Development · Updated on 2026-01-09
70
Participants Needed
3
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any gender Veteran of the US military between the ages of 18 and 65 years
- Ability to make independent decisions and provide informed consent
- Diagnosis of PTSD based on DSM-5 criteria and CAPS-5 symptom count
- CAPS-5 total score of 26 or higher in the past month
- Subjective cognitive impairment with a NeuroQoL Cognitive Function score of 25 or higher
You will not qualify if you...
- Diagnosis of bipolar I, schizophrenia spectrum, or other psychotic disorders
- Severe psychotic symptoms requiring antipsychotic treatment
- Moderate or severe substance use disorder (except caffeine and nicotine) in last 2 months
- History of severe traumatic brain injury
- Diagnosis of dementia or progressive neurocognitive disorder
- High suicide risk requiring inpatient treatment or recent suicidal behavior
- Pregnancy, lactation, or planned pregnancy during study; must use birth control if able to become pregnant
- Use of investigational drugs, methylphenidate, antipsychotics, mood stabilizers, stimulants, atomoxetine, or bupropion within 2 weeks prior to baseline
- Recent trauma-focused therapy for PTSD within 2 weeks before baseline
- Serious or uncontrolled medical or surgical illness contraindicating methylphenidate
- Prior allergic reaction to methylphenidate
- Litigation for psychiatric compensation outside Veterans benefits
- Current participation in another interventional PTSD trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233-1927
Actively Recruiting
2
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States, 35404-5015
Actively Recruiting
3
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108-1532
Actively Recruiting
Research Team
R
Rebecca C Hendrickson, MD PhD
CONTACT
C
Carolyn L Fort, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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