Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVA Office of Research and Development

About this trial

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

Qualifiers

Any gender Veteran of the US military between the ages of 18 and 65 years

Independent decision-making capacity to sign informed consent and HIPAA (i.e., no surrogate consent)

Diagnosis of PTSD defined by DSM-5 symptom count on CAPS-5

CAPS-5 past month total score greater than or equal to 26

Disqualifiers

Diagnosis of DSM-5-defined bipolar I, schizophrenia spectrum or other psychotic disorders (by MINI)

Presence of severe psychotic symptoms such that, based on the clinical judgement of the investigator or treatment provider, treatment with an antipsychotic is required.

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.

History of severe TBI as defined by the Ohio State University TBI Identification Method.

Trial design

Treatments tested in this trial

  • Methylphenidate
  • Placebo

Treatment groups

70 Participants
are divided into 2 treatment groups