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New treatment option for Posttraumatic Stress Disorder (PTSD)
Official title Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints
ClinicalTrials.gov ID: NCT05776056
What this study is testing
What is Methylphenidate?
Methylphenidate is an investigational medicine, given as an once-weekly, being studied as a potential treatment for posttraumatic stress disorder (ptsd).
Also referred to as Ritalin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Any gender Veteran of the US military between the ages of 18 and 65 years
- Independent decision-making capacity to sign informed consent and HIPAA (i.e., no surrogate consent)
- Diagnosis of PTSD defined by DSM-5 symptom count on CAPS-5
- 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...
You likely can't join if
- Diagnosis of DSM-5-defined bipolar I, schizophrenia spectrum or other psychotic disorders (by MINI)
- Presence of severe psychotic symptoms such that, based on the clinical judgement of the investigator or treatment provider, treatment with an...
- Diagnosis of moderate or severe substance use disorder (except for caffeine and nicotine) during the preceding 2 months. Patients who utilize alcohol...
- History of severe TBI as defined by the Ohio State University TBI Identification Method.
- Diagnosis of dementia or related progressive neurocognitive disorder, based on clinical records.
- Increased risk of suicide that necessitates inpatient treatment or treatment excluded by the protocol; and/or intensity of suicidal ideation (Type 4...
See the full eligibility criteria
- Any gender Veteran of the US military between the ages of 18 and 65 years
- Independent decision-making capacity to sign informed consent and HIPAA (i.e., no surrogate consent)
- Diagnosis of PTSD defined by DSM-5 symptom count on CAPS-5
- 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.
- Diagnosis of DSM-5-defined bipolar I, schizophrenia spectrum or other psychotic disorders (by MINI)
- Presence of severe psychotic symptoms such that, based on the clinical judgement of the investigator or treatment provider, treatment with an antipsychotic is required.
- 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...
- History of severe TBI as defined by the Ohio State University TBI Identification Method.
- Diagnosis of dementia or related progressive neurocognitive disorder, based on clinical records.
- 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...
- 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...
- Use of any investigational drug, MPH formulation, antipsychotics, mood stabilizers, monoamine oxidase inhibitors, stimulants, atomoxetine, or bupropion within 2 weeks of baseline.
- 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...
- A clinically significant acute or uncontrolled chronic medical/surgical illness that would contraindicate use of MPH, or a known terminal illness.
- Prior allergic reaction to any MPH formulation.
- Litigating for compensation for a psychiatric disorder outside the Veterans benefits compensation and pension process.
- Current enrollment in another treatment trial for PTSD.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tuscaloosa, Alabama, United States
- Seattle, Washington, United States
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tuscaloosa, Alabama, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.