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Central Nervous System Stimulant

Methylphenidate for Post-Traumatic Stress Disorder

Phase 4

Recruiting

Led By Murray A. Raskind, 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Study Summary

This trial will evaluate if methylphenidate can help Veterans with PTSD and associated neurocognitive issues. Using an innovative N-of-1 design, participants will alternate between the drug and placebo in a double-blind fashion to measure effectiveness.

Who is the study for?

This trial is for US military Veterans aged 18-65 with PTSD, who have trouble concentrating or remembering things. They must be able to consent and not be pregnant, planning pregnancy, or breastfeeding. Participants need a certain score on PTSD and cognitive tests but can't join if they have dementia, severe mental health issues like bipolar I or schizophrenia, recent substance abuse (except caffeine/nicotine), are at high risk of suicide, or are taking excluded medications.Check my eligibility

What is being tested?

The study tests Methylphenidate's effectiveness in treating PTSD-related cognitive issues in Veterans using an N-of-1 design. Each participant alternates between the drug and placebo every 4-5 weeks over 20 weeks under double-blind conditions to compare changes in symptoms during different treatment periods.See study design

What are the potential side effects?

While not explicitly listed here, common side effects of Methylphenidate include nervousness, trouble sleeping, loss of appetite, weight loss, dizziness, nausea, vomiting or headache. The severity and occurrence can vary from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

PTSD Symptom Checklist for DSM-5 (PCL-5)

Secondary outcome measures

Neuro-QoL Cognitive Function short form (NeuroQoL)

Symbol Digit Coding (SDC)

Trial Design

2Treatment groups

Experimental Treatment

Group I: N-of-1 crossover study enrollment: start with placeboExperimental Treatment2 Interventions

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).

Group II: N-of-1 crossover study enrollment: start with methylphenidateExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylphenidate

2014

Completed Phase 4

~431850

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,214 Total Patients Enrolled

Murray A. Raskind, MDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA

3 Previous Clinical Trials

333 Total Patients Enrolled

Media Library

Methylphenidate (Central Nervous System Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT05776056 — Phase 4

Post-Traumatic Stress Disorder Research Study Groups: N-of-1 crossover study enrollment: start with placebo, N-of-1 crossover study enrollment: start with methylphenidate

Post-Traumatic Stress Disorder Clinical Trial 2023: Methylphenidate Highlights & Side Effects. Trial Name: NCT05776056 — Phase 4

Methylphenidate (Central Nervous System Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05776056 — Phase 4

Frequently Asked Questions

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

Has this treatment been accepted by the governmental health agency?

"There is ample evidence to support its safety, therefore this treatment has been awarded a 3 on our team's scale. As it stands, the therapy has already achieved Phase 4 certification."

Answered by AI

Are there any current vacancies for those wishing to participate in this research?

"Clinicaltrials.gov confirms that this research is no longer recruiting volunteers, as the trial first posted in August 1st 2023 has not been updated since March 8th 2023. However, there are currently 410 different trials actively looking for participants at present."

Answered by AI

Could those under 30 years of age participate in this clinical experiment?

"According to the parameters of this trial, adults aged 18-65 are eligible for participation. Conversely, there are 41 trials specifically targeting minors and 329 research studies that target senior citizens."

Answered by AI

Who has the capacity to join this medical experiment?

"To be eligible for this trial, applicants must have been diagnosed with PTSD and fall between 18 to 65 years of age. It is estimated that 70 people will need to enrolled in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints

2024. "Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05776056.