Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints

NCT ID
NCT05776056
Registry status
Recruiting
Study type
Interventional
Phase
Phase 4
Sponsor
VA Office of Research and Development
Conditions
Posttraumatic Stress Disorder (PTSD)

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 70 participants (Estimated).

What is being studied

  • Intervention: Acids, Carbocyclic
  • Intervention: Carboxylic Acids
  • Intervention: Heterocyclic Compounds
  • Intervention: Heterocyclic Compounds, 1-Ring
  • Drug: Methylphenidate
  • Intervention: Methylphenidate
  • Intervention: Organic Chemicals
  • Intervention: Phenylacetates
  • Intervention: Piperidines
  • Drug: Placebo

Who may be eligible

Ages
18 Years to 65 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: 1. Any gender Veteran of the US military 2. Independent decision-making capacity to sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) (i.e., no surrogate consent) 3. Diagnosis of PTSD defined by DSM-5 symptom count on Clinician-Administered PTSD Scale for DSM-5 (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 Tetrahydrocannabinol (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

Study locations

3 study locations are listed.

Recruiting site status is explicitly provided for 3 locations; 3 are listed as Recruiting.

Countries: United States

  • Alabama, United States: 2
  • Washington, United States: 1

Sample of listed locations

  • Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama, 35233-1927, United States — Recruiting
  • Tuscaloosa VA Medical Center, Tuscaloosa, AL — Tuscaloosa, Alabama, 35404-5015, United States — Recruiting
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, 98108-1532, United States — Recruiting

Study details

Start date
February 5, 2024
Primary completion date
March 31, 2027
Completion date
September 30, 2027
First posted
March 20, 2023

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT05776056
Registry last updated
August 19, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT05776056 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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