70 Participants Needed

Methylphenidate for Post-Traumatic Stress Disorder

(IMPACT Trial)

Recruiting at 2 trial locations
RC
CL
Overseen ByCarolyn L Fort, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as antipsychotics, mood stabilizers, monoamine oxidase inhibitors, stimulants, atomoxetine, or bupropion, at least 2 weeks before starting. If you are receiving trauma-focused therapy for PTSD, you must complete it before joining the study.

Is methylphenidate generally safe for use in humans?

Methylphenidate, used in various forms for treating ADHD, is generally considered safe and well-tolerated in children and adolescents. Common side effects include decreased appetite, insomnia, and irritability, but serious adverse events are rare. Safety studies show no unexpected safety concerns, and the drug is comparable to other stimulant treatments.12345

How does the drug methylphenidate differ from other drugs for PTSD?

Methylphenidate, commonly used for ADHD, is being explored for PTSD due to its potential to improve cognitive and emotional symptoms, which is different from the more commonly used antidepressants like SSRIs. This drug showed promising results in a small study, suggesting it might help with cognitive complaints and PTSD symptoms, but more research is needed to confirm its effectiveness.678910

What evidence supports the effectiveness of the drug Methylphenidate for treating PTSD?

A small pilot study found that Methylphenidate led to significant improvements in cognitive complaints and PTSD symptoms compared to a placebo, suggesting it may help with emotional and cognitive issues in PTSD. However, larger studies are needed to confirm these findings.67101112

Who Is on the Research Team?

RC

Rebecca C. Hendrickson, MD PhD

Principal Investigator

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

CAPS-5 past month total score greater than or equal to 26
Subjective neurocognitive impairment, defined as a total score of greater than or equal to 25 (1 standard deviation below the mean) on the NeuroQoL Cognitive Function 8-item self-report form.
I have been diagnosed with PTSD according to DSM-5.
See 2 more

Exclusion Criteria

I have completed a trauma-focused therapy for PTSD within the last 2 weeks.
Prior allergic reaction to any MPH formulation
Current enrollment in another interventional trial for PTSD
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sequential 4-week periods of methylphenidate and placebo, in randomized order, separated by 1-week washout periods, for a total of 20 weeks

20 weeks
Weekly or biweekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Methylphenidate
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: N-of-1 crossover study enrollment: start with placeboExperimental Treatment2 Interventions
Group II: N-of-1 crossover study enrollment: start with methylphenidateExperimental Treatment2 Interventions

Methylphenidate is already approved in United States, Canada, European Union for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Methylphenidate for:
πŸ‡¨πŸ‡¦
Approved in Canada as Methylphenidate for:
πŸ‡ͺπŸ‡Ί
Approved in European Union as Methylphenidate for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Published Research Related to This Trial

In a 12-week trial involving 32 participants with PTSD and/or TBI, methylphenidate significantly improved cognitive complaints compared to placebo, indicating its potential efficacy for these conditions.
The treatment was well tolerated, suggesting a favorable safety profile, but further research with a larger sample size is needed to confirm these promising results.
Randomized Placebo-Controlled Trial of Methylphenidate or Galantamine for Persistent Emotional and Cognitive Symptoms Associated with PTSD and/or Traumatic Brain Injury.McAllister, TW., Zafonte, R., Jain, S., et al.[2018]
Selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, paroxetine, and sertraline show a statistically significant but small effect in reducing PTSD symptoms compared to placebo, based on a systematic review of 115 randomized controlled trials.
Prazosin and risperidone also demonstrate small positive effects when used to augment other treatments, but no single pharmacological intervention was found to be superior to others in head-to-head comparisons.
Pharmacological therapy for post-traumatic stress disorder: a systematic review and meta-analysis of monotherapy, augmentation and head-to-head approaches.Hoskins, MD., Bridges, J., Sinnerton, R., et al.[2023]
A review of 18 clinical trials found that atypical antipsychotics, particularly risperidone and quetiapine, provide a modest benefit in treating PTSD symptoms, especially intrusive thoughts and hypervigilance.
The effect sizes from double-blind placebo-controlled trials were small, indicating that while there is some positive response, larger studies are necessary to better understand the effectiveness and potential side effects of these medications.
A review of atypical antipsychotic medications for posttraumatic stress disorder.Ahearn, EP., Juergens, T., Cordes, T., et al.[2015]

Citations

Randomized Placebo-Controlled Trial of Methylphenidate or Galantamine for Persistent Emotional and Cognitive Symptoms Associated with PTSD and/or Traumatic Brain Injury. [2018]
Pharmacological therapy for post-traumatic stress disorder: a systematic review and meta-analysis of monotherapy, augmentation and head-to-head approaches. [2023]
A review of atypical antipsychotic medications for posttraumatic stress disorder. [2015]
Effectiveness, Acceptability and Safety of Pharmaceutical Management for Combat-Related PTSD in Adults Based on Systematic Review of Twenty-Two Randomized Controlled Trials. [2022]
Evidence-based pharmacotherapy of post-traumatic stress disorder (PTSD). [2022]
A postmarketing clinical experience study of Metadate CD. [2019]
Safety and Tolerability of Serdexmethylphenidate/Dexmethylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder: A 12-Month, Open-Label Safety Study. [2023]
A Randomized, Controlled Laboratory Classroom Study of Serdexmethylphenidate and d-Methylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder. [2021]
Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Titration Study of Methylphenidate Hydrochloride Extended-Release Capsules (Aptensio XR) in Preschool Children with Attention-Deficit/Hyperactivity Disorder. [2021]
Methylphenidate controlled-delivery capsules (EquasymXL, Metadate CD): a review of its use in the treatment of children and adolescents with attention-deficit hyperactivity disorder. [2018]
Post-traumatic stress disorder: emerging concepts of pharmacotherapy. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
What might the psychobiology of posttraumatic stress disorder teach us about future approaches to pharmacotherapy? [2013]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security