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NCT04885257 · ClinicalTrials.gov registry record · Phase 1

Methylphenidate for Ptsd and Stroke Veterans

A Phase 1 study of Stroke and PTSD, sponsored by VA Office of Research and Development.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target
1
Study location

NCT04885257 is a Phase 1 study of Stroke and PTSD that has completed, run by VA Office of Research and Development. The registered enrollment target is 20 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04885257, a Phase 1 study of Stroke and PTSD, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

Veterans with post-traumatic stress disorder (PTSD) have an increased risk of developing ischemic stroke. Veterans enduring PTSD face difficulties in managing their PTSD severity after suffering from a stroke. Currently, clinical trials in PTSD exclude patients with stroke and patients with significant premorbid psychological conditions like PTSD are usually excluded from stroke clinical trials. Methylphenidate (MPH) is a central nervous system stimulant that can improve PTSD symptoms: avoidance behaviors, social withdrawal, hyperarousal, and working memory. MPH can also improve post-stroke outcomes: mood, activities of daily living, and motor functioning. In clinical trials for PTSD or stroke, MPH has been shown to be well-tolerated with minimal adverse events. The high prevalence of PTSD in Veterans with stroke provides strong justification for development of interventions that effectively and simultaneously target both conditions. The overarching goal of our proposal is to understand how MPH improves PTSD severity in Veterans with comorbid stroke.

Conditions Studied

Stroke PTSD

Interventions

  • DRUG Placebo
  • DRUG Methylphenidate

Study Locations (1)

Alabama

  • Birmingham VA Medical Center, Birmingham, AL - Birmingham

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2022-01-14
Est. Completion 2025-05-05
Phase Phase 1

Sponsor

VA Office of Research and Development

1,668 total trials

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What the Registry Record Tells You About NCT04885257

The ClinicalTrials.gov registry entry for NCT04885257 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04885257 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.

Frequently Asked Questions

What is clinical trial NCT04885257 about?

NCT04885257 is a clinical study titled "Methylphenidate for Ptsd and Stroke Veterans". Veterans with post-traumatic stress disorder (PTSD) have an increased risk of developing ischemic stroke. Veterans enduring PTSD face difficulties in managing their PTSD severity after suffering from a stroke. Currently, clinical trials in PTSD exclude patients with stroke and patients with signific...

What is the current status of trial NCT04885257?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2022-01-14. Estimated completion is 2025-05-05.

What conditions does trial NCT04885257 study?

This clinical trial studies the following conditions: Stroke, PTSD.

What interventions are being tested in trial NCT04885257?

The interventions under investigation include: Placebo (DRUG), Methylphenidate (DRUG).

Who is sponsoring clinical trial NCT04885257?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04885257 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.