What side effects are associated with this type of intervention?

The most common treatments for Post-Traumatic Stress Disorder (PTSD) include SSRIs (Selective Serotonin Reuptake Inhibitors), SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors), and trauma-focused psychotherapies. SSRIs and SNRIs can cause side effects such as nausea, insomnia, sexual dysfunction, and increased anxiety. Methylphenidate, a central nervous system stimulant being studied for PTSD, is generally well-tolerated but can cause side effects like increased heart rate, insomnia, anxiety, and potential for abuse. Trauma-focused psychotherapies, such as cognitive-behavioral therapy (CBT), typically have fewer side effects but may cause temporary increases in distress as patients confront traumatic memories.

What other types of research exist?

Promising, novel alternatives to Methylphenidate for PTSD patients include Selegiline, which has shown clinical efficacy and safety in related conditions, and Gabapentin, which has been studied for anxiety disorders and may have potential for PTSD treatment. Additionally, low-dose Methylphenidate for prevention in high-risk populations and integrative approaches combining medication with non-pharmacological interventions are areas of interest.

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Central Nervous System Stimulant

Methylphenidate for Post-Traumatic Stress Disorder

Q: What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Post-Traumatic Stress Disorder (PTSD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications help manage symptoms by altering neurotransmitter levels in the brain. While methylphenidate, a central nervous system stimulant, is being studied for its potential benefits in PTSD, it is not currently FDA-approved for this condition. Other treatments under investigation include prazosin, an alpha-adrenergic receptor blocker, which has shown mixed results in clinical trials for reducing PTSD-related nightmares and improving sleep quality.

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

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

Willing to refrain from antipsychotics, mood stabilizers, stimulants, and any formulation of MPH

Must not have

Treatment with evidence-based trauma-focused therapy for PTSD within two weeks of baseline (if participant is receiving therapy, he/she must complete treatment prior to entering study)

Poor pre-stroke baseline function of a modified Rankin score >2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 6 months

Awards & highlights

Summary

This trial aims to see if the medication Methylphenidate (MPH) can help Veterans who have both PTSD and have had a stroke. MPH is thought to improve brain function, which may reduce PTSD symptoms and help with stroke recovery. Methylphenidate (MPH) is a stimulant drug commonly used to treat attention-deficit hyperactivity disorder (ADHD) and has shown potential in treating cognitive and emotional symptoms in various neuropsychiatric conditions.

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have completed a PTSD therapy program before joining the study.

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I had difficulty with daily activities before my stroke.

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I don't have any health issues that would make it unsafe for me to use MPH.

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I have been diagnosed with a specific mental health condition like bipolar disorder or schizophrenia.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinician-Administered Post-traumatic stress disorder scale

Secondary study objectives

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%

Dull, tired, listless

21%

Worried/Anxious

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 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Methylphenidate, a central nervous system stimulant, improves PTSD symptoms by enhancing dopamine and norepinephrine activity, which can help with mood regulation, attention, and reducing hyperarousal. SSRIs and SNRIs, such as sertraline and venlafaxine, work by increasing serotonin and norepinephrine levels in the brain, which can alleviate anxiety, depression, and other PTSD symptoms. Alpha-adrenergic receptor blockers like prazosin are used to reduce nightmares and improve sleep quality by blocking the effects of norepinephrine. These treatments are crucial for PTSD patients as they target different aspects of the disorder, helping to manage a wide range of symptoms and improve overall quality of life.

PTSD: from neurobiology to pharmacological treatments.Nonconventional interventions for chronic post-traumatic stress disorder: Ketamine, repetitive trans-cranial magnetic stimulation (rTMS), and alternative approaches.