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Central Nervous System Stimulant

Methylphenidate for Post-Traumatic Stress Disorder

Phase 2

Recruiting

Led By Chen Lin, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

First-ever symptomatic ischemic stroke radiologically verified, occurring within past 1-12 months

Females of child-bearing potential must be using a medically acceptable method of birth control and should not be pregnant nor have plans for pregnancy or breastfeeding during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 6 months

Awards & highlights

Study Summary

This trial will test how well methylphenidate (MPH) works in treating PTSD symptoms in veterans with comorbid ischemic stroke.

Who is the study for?

This trial is for US military veterans who have both PTSD and a recent ischemic stroke. They must not be on certain psychiatric medications, have had their first-ever stroke within the last year, and women must use birth control if of child-bearing potential. Exclusions include severe cognitive impairment, major psychiatric disorders other than PTSD, or being in another intervention trial.Check my eligibility

What is being tested?

The study tests whether Methylphenidate (MPH), a stimulant that can improve PTSD symptoms and post-stroke recovery, is effective for veterans with both conditions. Participants will either receive MPH or a placebo to compare outcomes.See study design

What are the potential side effects?

Methylphenidate is generally well-tolerated but may cause minimal side effects such as nervousness, trouble sleeping, loss of appetite, weight loss, dizziness, nausea, vomiting or headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had my first stroke, confirmed by scans, between 1 to 12 months ago.

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I am using birth control and am not pregnant or planning to become pregnant or breastfeed during the study.

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I am willing to stop taking antipsychotics, mood stabilizers, stimulants, and any form of MPH.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinician-Administered Post-traumatic stress disorder scale

Secondary outcome measures

Modified Rankin Scale

Side effects data

From 2020 Phase 4 trial • 267 Patients • NCT02039908

51%

Appetite Loss

40%

Insomnia

33%

Irritability

29%

Picking at skin, nailbiting

21%

Worried/Anxious

21%

Dull, tired, listless

19%

Tearful, depressed

18%

Stomachache

13%

Headache

13%

Motor Tics

12%

Buccal-lingual movements

10%

Social Withdrawal

Hospitalized

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1-Medication First

Phase 1 - Placebo First

Phase 2 - 7-Day Dosing

Phase 2 - 5-Day Dosing

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MethylphenidateExperimental Treatment1 Intervention

Patient with both PTSD and recent history of stroke. Methylphenidate active arm. The oral dosing maximum will be up to 20mg twice daily.

Group II: PlaceboPlacebo Group1 Intervention

Patient with both PTSD and recent history of stroke. Placebo control arm. The frequency will be up to twice a day, with oral dosing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylphenidate

2014

Completed Phase 4

~431850

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,543 Total Patients Enrolled

Chen Lin, MDPrincipal InvestigatorBirmingham VA Medical Center, Birmingham, AL

2 Previous Clinical Trials

37 Total Patients Enrolled

Media Library

Methylphenidate (Central Nervous System Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT04885257 — Phase 2

Post-Traumatic Stress Disorder Research Study Groups: Placebo, Methylphenidate

Post-Traumatic Stress Disorder Clinical Trial 2023: Methylphenidate Highlights & Side Effects. Trial Name: NCT04885257 — Phase 2

Methylphenidate (Central Nervous System Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04885257 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other research has been done on Methylphenidate's effect?

"At the moment, there are 30 clinical trials being conducted to research Methylphenidate. Out of those active studies, 2 have reached Phase 3. The majority of the research is based in Lexington, Kentucky; however, 43 different locations are running trials for this treatment."

Answered by AI

Is Methylphenidate known to have harmful side effects?

"Methylphenidate has received a score of 2. This is because, although there is data supporting its safety, none exists yet for efficacy in humans."

Answered by AI

How many people are being given the chance to participate in this experiment?

"That is correct. The information available on clinicaltrials.gov affirms that this study is still recruiting patients. This trial was first posted on January 14th, 2022 and was edited last on January 18th, 2022. Currently, the plan is to have 60 participants across 1 site."

Answered by AI

Are people still being recruited to participate in this clinical trial?

"The trial, which can be found on clinicaltrials.gov, is looking for patients at the moment. The listing was put up on January 14th and updated on January 18th of this year."

Answered by AI