NCT05776056 Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints
| NCT ID | NCT05776056 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | VA Office of Research and Development |
| Condition | Posttraumatic Stress Disorder (PTSD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-02-05 |
| Primary Completion | 2026-07-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 70 participants in total. It began in 2024-02-05 with a primary completion date of 2026-07-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Any gender Veteran of the US military between the ages of 18 and 65 years 2. Independent decision-making capacity to sign informed consent and HIPAA (i.e., no surrogate consent) 3. Diagnosis of PTSD defined by DSM-5 symptom count on CAPS-5 4. CAPS-5 past month total score greater than or equal to 26 5. Subjective neurocognitive impairment, defined as a total score of greater than or equal to 25 (1 standard deviation below the mean) on the NeuroQoL Cognitive Function 8-item self-report form. Exclusion Criteria: 1. Diagnosis of DSM-5-defined bipolar I, schizophrenia spectrum or other psychotic disorders (by MINI) 2. Presence of severe psychotic symptoms such that, based on the clinical judgement of the investigator or treatment provider, treatment with an antipsychotic is required. 3. Diagnosis of moderate or severe substance use disorder (except for caffeine and nicotine) during the preceding 2 months. Patients who utilize alcohol or cannabis but do not meet criteria for moderate or severe disorder are permitted at the discretion of the investigator. Participants must agree to abstain from illicit drugs, including cannabis products containing THC even when legal by state law. 4. History of severe TBI as defined by the Ohio State University TBI Identification Method. 5. Diagnosis of dementia or related progressive neurocognitive disorder, based on clinical records. 6. Increased risk of suicide that necessitates inpatient treatment or treatment excluded by the protocol; and/or intensity of suicidal ideation (Type 4 or Type 5) or any suicidal behavior in the past 2 months on Columbia Suicide Severity Rating Scale (C-SSRS). 7. Pregnancy or lactation, or anticipated pregnancy at any point during study participation. Participants of child-bearing potential must have negative pregnancy test at study entry and must agree to adhere to a medically acceptable method of birth control (e.g., oral, implantable, injectable, or transdermal hormone-based contraceptives; intrauterine device; double-barrier method). 8. Use of any investigational drug, MPH formulation, antipsychotics, mood stabilizers, monoamine oxidase inhibitors, stimulants, atomoxetine, or bupropion within 2 weeks of baseline. 9. Treatment with evidence-based trauma-focused therapy for PTSD within 2 weeks of baseline (if participant is receiving therapy, he/she must complete treatment prior to entering study). Supportive psychotherapy may be continued during the study. 10. A clinically significant acute or uncontrolled chronic medical/surgical illness that would contraindicate use of MPH, or a known terminal illness. 11. Prior allergic reaction to any MPH formulation. 12. Litigating for compensation for a psychiatric disorder outside the Veterans benefits compensation and pension process. 13. Current enrollment in another interventional trial for PTSD.
Contact & Investigator
Rebecca C. Hendrickson, MD PhD
PRINCIPAL INVESTIGATOR
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Frequently Asked Questions
Who can join the NCT05776056 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Posttraumatic Stress Disorder (PTSD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05776056 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05776056 currently recruiting?
Yes, NCT05776056 is actively recruiting participants. Contact the research team at Rebecca.Hendrickson@va.gov for enrollment information.
Where is the NCT05776056 trial being conducted?
This trial is being conducted at Birmingham, United States, Tuscaloosa, United States, Seattle, United States.
Who is sponsoring the NCT05776056 clinical trial?
NCT05776056 is sponsored by VA Office of Research and Development. The principal investigator is Rebecca C. Hendrickson, MD PhD at VA Puget Sound Health Care System Seattle Division, Seattle, WA. The trial plans to enroll 70 participants.
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