RECRUITING

Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints

Conditions

Posttraumatic Stress Disorder (PTSD)PTSD Posttraumatic Stress Disorder ADHD Neurocognitive Stimulant Veteran Traumatic Brain Injury TBI Methylphenidate

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized Placebo-Controlled Trial of Methylphenidate for the Treatment of Post-Traumatic Stress Disorder With Associated Neurocognitive Complaints

Quick Facts

Study Start:2024-02-05

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05776056

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Any gender Veteran of the US military between the ages of 18 and 65 years 2. Independent decision-making capacity to sign informed consent and HIPAA (i.e., no surrogate consent) 3. Diagnosis of PTSD defined by DSM-5 symptom count on CAPS-5 4. CAPS-5 past month total score greater than or equal to 26 5. 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.	1. Diagnosis of DSM-5-defined bipolar I, schizophrenia spectrum or other psychotic disorders (by MINI) 2. Presence of severe psychotic symptoms such that, based on the clinical judgement of the investigator or treatment provider, treatment with an antipsychotic is required. 3. Diagnosis of moderate or severe substance use disorder (except for caffeine and nicotine) during the preceding 2 months. Patients who utilize alcohol or cannabis but do not meet criteria for moderate or severe disorder are permitted at the discretion of the investigator. Participants must agree to abstain from illicit drugs, including cannabis products containing THC even when legal by state law. 4. History of severe TBI as defined by the Ohio State University TBI Identification Method. 5. Diagnosis of dementia or related progressive neurocognitive disorder, based on clinical records. 6. Increased risk of suicide that necessitates inpatient treatment or treatment excluded by the protocol; and/or intensity of suicidal ideation (Type 4 or Type 5) or any suicidal behavior in the past 2 months on Columbia Suicide Severity Rating Scale (C-SSRS). 7. Pregnancy or lactation, or anticipated pregnancy at any point during study participation. Participants of child-bearing potential must have negative pregnancy test at study entry and must agree to adhere to a medically acceptable method of birth control (e.g., oral, implantable, injectable, or transdermal hormone-based contraceptives; intrauterine device; double-barrier method). 8. Use of any investigational drug, MPH formulation, antipsychotics, mood stabilizers, monoamine oxidase inhibitors, stimulants, atomoxetine, or bupropion within 2 weeks of baseline. 9. Treatment with evidence-based trauma-focused therapy for PTSD within 2 weeks of baseline (if participant is receiving therapy, he/she must complete treatment prior to entering study). Supportive psychotherapy may be continued during the study. 10. A clinically significant acute or uncontrolled chronic medical/surgical illness that would contraindicate use of MPH, or a known terminal illness. 11. Prior allergic reaction to any MPH formulation. 12. Litigating for compensation for a psychiatric disorder outside the Veterans benefits compensation and pension process. 13. Current enrollment in another interventional trial for PTSD.

Inclusion Criteria

Exclusion Criteria

1. Any gender Veteran of the US military between the ages of 18 and 65 years
2. Independent decision-making capacity to sign informed consent and HIPAA (i.e., no surrogate consent)
3. Diagnosis of PTSD defined by DSM-5 symptom count on CAPS-5
4. CAPS-5 past month total score greater than or equal to 26
5. 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.

1. Diagnosis of DSM-5-defined bipolar I, schizophrenia spectrum or other psychotic disorders (by MINI)
2. Presence of severe psychotic symptoms such that, based on the clinical judgement of the investigator or treatment provider, treatment with an antipsychotic is required.
3. Diagnosis of moderate or severe substance use disorder (except for caffeine and nicotine) during the preceding 2 months. Patients who utilize alcohol or cannabis but do not meet criteria for moderate or severe disorder are permitted at the discretion of the investigator. Participants must agree to abstain from illicit drugs, including cannabis products containing THC even when legal by state law.
4. History of severe TBI as defined by the Ohio State University TBI Identification Method.
5. Diagnosis of dementia or related progressive neurocognitive disorder, based on clinical records.
6. Increased risk of suicide that necessitates inpatient treatment or treatment excluded by the protocol; and/or intensity of suicidal ideation (Type 4 or Type 5) or any suicidal behavior in the past 2 months on Columbia Suicide Severity Rating Scale (C-SSRS).
7. Pregnancy or lactation, or anticipated pregnancy at any point during study participation. Participants of child-bearing potential must have negative pregnancy test at study entry and must agree to adhere to a medically acceptable method of birth control (e.g., oral, implantable, injectable, or transdermal hormone-based contraceptives; intrauterine device; double-barrier method).
8. Use of any investigational drug, MPH formulation, antipsychotics, mood stabilizers, monoamine oxidase inhibitors, stimulants, atomoxetine, or bupropion within 2 weeks of baseline.
9. Treatment with evidence-based trauma-focused therapy for PTSD within 2 weeks of baseline (if participant is receiving therapy, he/she must complete treatment prior to entering study). Supportive psychotherapy may be continued during the study.
10. A clinically significant acute or uncontrolled chronic medical/surgical illness that would contraindicate use of MPH, or a known terminal illness.
11. Prior allergic reaction to any MPH formulation.
12. Litigating for compensation for a psychiatric disorder outside the Veterans benefits compensation and pension process.
13. Current enrollment in another interventional trial for PTSD.

Contacts and Locations

Study Contact

Rebecca C Hendrickson, MD PhD

CONTACT

(206) 277-5054

Rebecca.Hendrickson@va.gov

Rebecca Stone

CONTACT

Principal Investigator

Murray A. Raskind, MD

PRINCIPAL_INVESTIGATOR

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

Study Locations (Sites)

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404-5015

United States

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

Seattle, Washington, 98108-1532

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Murray A. Raskind, MD, PRINCIPAL_INVESTIGATOR, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-05

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2024-02-05

Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

PTSD
Posttraumatic Stress Disorder
ADHD
Neurocognitive
Stimulant
Veteran
Traumatic Brain Injury
TBI
Methylphenidate

Additional Relevant MeSH Terms

Posttraumatic Stress Disorder (PTSD)