Randomized Placebo-Controlled Trial of Methylphenidate for the Treatment of Post-Traumatic Stress Disorder With Associated Neurocognitive Complaints
VA Office of Research and Development
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.
Description
Background: Posttraumatic stress disorder (PTSD) is a chronic psychiatric illness that is associated with significant suffering and disability in Veterans. Current treatment options are not fully effective for all Veterans, and even when they are effective in lowering total symptom burden, many Veterans continue to experience significant symptom burden and associated functional impairment. Total symptom burden and associated functional impairment is often particularly high for those with comorbid mild traumatic brain injury (mTBI). Methylphenidate (MPH) is a widely available psychostimulant me…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 spe…
Interventions
- DrugMethylphenidate
Methylphenidate 10mg will be taken twice daily.
- DrugPlacebo
An inactive pill (placebo) will be taken twice daily.
Locations (3)
- Birmingham VA Medical Center, Birmingham, ALBirmingham, Alabama
- Tuscaloosa VA Medical Center, Tuscaloosa, ALTuscaloosa, Alabama
- VA Puget Sound Health Care System Seattle Division, Seattle, WASeattle, Washington