Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
VA Office of Research and Development
Study ID
NCT05776056
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Posttraumatic Stress Disorder (PTSD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Methylphenidate — DRUG
    Methylphenidate 10mg will be taken twice daily.
  • Placebo — DRUG
    An inactive pill (placebo) will be taken twice daily.

Study Details

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.

Key Dates

Start date
Feb 5, 2024
Status verified
Jan 2026
Primary completion
Jul 6, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

PTSD Symptom Checklist for DSM-5 (PCL-5) [ Time Frame: 4 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Birmingham VA Medical Center, Birmingham, ALBirminghamAlabama35233-1927
Lori Davis, MD
205-835-6962
Anchal Ghera, BS
(205) 9338101
Tuscaloosa VA Medical Center, Tuscaloosa, ALTuscaloosaAlabama35404-5015
Lori Davis, MD
205-835-6962
Anchal Ghera, BS
(205) 9338101
VA Puget Sound Health Care System Seattle Division, Seattle, WASeattleWashington98108-1532
Rebekah J Rein, JD
[email protected]
206-764-2711
Murray A Raskind, MD
[email protected]
(206) 764-2702
Murray A. Raskind, MD (SUB_INVESTIGATOR)
Rebecca C. Hendrickson, MD PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Birmingham VA Medical Center, Birmingham, AL· Birmingham, ALTuscaloosa VA Medical Center, Tuscaloosa, AL· Tuscaloosa, ALVA Puget Sound Health Care System Seattle Division, Seattle, WA· Seattle, WA

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