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Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints

Study acronym: IMPACT
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Jul 6, 2026 → Mar 31, 2027
See other at-risk trials from VA Office of Research and Development

Record History

  1. Primary completion pushed from Jul 6, 2026 to Mar 31, 2027 Completion pushed from Mar 31, 2027 to Sep 30, 2027 · Site contacts updated at 1 of 3 sites · Eligibility criteria expanded, about 4 wordsv9 Show 3 more changesShow less
    • Completion pushed from Mar 31, 2027 to Sep 30, 2027
    • Site contacts updated at 1 of 3 sites
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv8
  3. Study sites: 2 to 3v7
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 22, 2024 to Feb 5, 2024 · Site details revised at 2 of 2 sitesv6 Show 2 more changesShow less
    • Start date changed from estimate of Jan 22, 2024 to Feb 5, 2024
    • Site details revised at 2 of 2 sites
  5. Start date: Dec 4, 2023 to Jan 22, 2024v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Oct 2, 2023 to Dec 4, 2023v4
  2. Start date: Aug 1, 2023 to Oct 2, 2023 Site contacts updated at 1 of 2 sitesv3 Show 1 more changeShow less
    • Site contacts updated at 1 of 2 sites
  3. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05776056
Lead Sponsor VA Office of Research and Development
Conditions Posttraumatic Stress Disorder (PTSD)
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov