Using methylphenidate to treat PTSD and cognitive issues in veterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of methylphenidate, a stimulant medication, in treating posttraumatic stress disorder (PTSD) and associated neurocognitive complaints in veterans. The innovative N-of-1 design allows each participant to alternate between receiving methylphenidate and a placebo every 4-5 weeks over a 20-week period, ensuring a robust comparison of treatment effects. The study aims to assess changes in PTSD symptoms and cognitive functioning through this randomized, double-blind approach. Results from this trial could provide valuable insights into new treatment options for veterans struggling with PTSD.

Why it matters

Who can join: the full rules

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

Where it's running

• Birmingham VA Medical Center, Birmingham, AL
  Birmingham, Alabama, United States Recruiting
• Tuscaloosa VA Medical Center, Tuscaloosa, AL
  Tuscaloosa, Alabama, United States Recruiting
• VA Puget Sound Health Care System Seattle Division, Seattle, WA
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Rebecca C. Hendrickson, MD PhD — VA Puget Sound Health Care System Seattle Division, Seattle, WA
• Study coordinator: Rebecca C Hendrickson, MD PhD
• Email: Rebecca.Hendrickson@va.gov
• Phone: (206) 277-5054

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Deep Brain Reorienting for PTSD in Veterans

  This study tests whether Deep Brain Reorienting can help reduce PTSD symptoms in military veterans compared with usual care.

  Recruiting University of Alberta · Edmonton, Alberta · NCT07840417

• Trauma recovery options for veterans: comparing HRV biofeedback and present-centered therapy

  This trial tests whether Heart Rate Variability Biofeedback plus trauma-informed care helps veterans with PTSD and substance use issues more than present-centered therapy.

  Recruiting Phase 2/3 Coatesville VA Medical Center · Coatesville, Pennsylvania · NCT07756723

• CIDI 5.0 validation against SCID-5 for lifetime mental disorders in Hong Kong adults

  This study tests whether the CIDI 5.0 interview can reliably identify lifetime mental disorders in adults in Hong Kong by comparing it with the SCID-5 diagnostic interview.

  Recruiting The University of Hong Kong · Hong Kong · NCT07604753

• Two-week intensive outpatient trauma program for PTSD

  This program will test whether a two-week outpatient course combining Prolonged Exposure and EMDR reduces PTSD symptoms and improves functioning in adults with PTSD.

  Recruiting Oslo University Hospital · Oslo · NCT07565311

• Side-by-Side Testing of SPARCS and the Unified Protocol for Youth with Chronic Illness and Trauma

  This trial tests whether two trauma-focused therapies (SPARCS and the Unified Protocol) help kids and teens with chronic medical conditions feel less trauma-related distress and function better, delivered in group or individual formats.

  Recruiting Ann & Robert H Lurie Children's Hospital of Chicago · Chicago, Illinois · NCT07483333

• Metacognitive Therapy vs Cognitive-Behavioral Therapy for Anxiety Disorders

  This study asks people with generalized anxiety disorder, social anxiety disorder, or PTSD to share their experiences after trying metacognitive therapy or disorder-specific cognitive-behavioral therapy in a randomized trial.

  Recruiting Karolinska Institutet · Stockholm · NCT07382323

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.