Post-Traumatic Stress Disorder (PTSD) Clinical Trials

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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

• 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.

Locations
United States
Alabama
Birmingham VA Medical Center, Birmingham, AL
RECRUITING
Birmingham
Tuscaloosa VA Medical Center, Tuscaloosa, AL
RECRUITING
Tuscaloosa
Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
RECRUITING
Seattle
Contact Information
Primary
Rebecca C Hendrickson, MD PhD
Rebecca.Hendrickson@va.gov
(206) 277-5054
Backup
Carolyn L Fort, BS
carolyn.fort@va.gov
(206) 768-5259
Time Frame
Start Date: 2024-02-05
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 70
Treatments
Other: N-of-1 crossover study enrollment: start with placebo
All participants spend time receiving both active study drug (methylphenidate) and placebo (sham study drug), in randomized order, across 4 treatment blocks separated by 1 week washout periods (where no study drug is given).
Other: N-of-1 crossover study enrollment: start with methylphenidate
All participants spend time receiving both active study drug (methylphenidate) and placebo (sham study drug), in randomized order, across 4 treatment blocks separated by 1 week washout periods (where no study drug is given).
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov