Methylphenidate for Ptsd and Stroke Veterans

Korábbi kezelés

• Increased risk of suicide that necessitates inpatient treatment or warrants additional therapy excluded by the protocol; and/or intensity of suicidal ideation (Type 4 or Type 5) or any suicidal behavior in the past 3 months on Columbia Suicide Severity Rating Scale (C-SSRS)
• Use of any investigational drug, MPH formulation, antipsychotics, mood stabilizers, monoamine oxidase inhibitors, stimulants or any medication known to be a potent (strong) cytochrome P450 subtype 3A4 inhibitor within 2 weeks of baseline
• 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)
  • Supportive psychotherapy in process at time of Screening may be continued during the study.
• Litigating for compensation for a psychiatric disorder. Veterans who are in the process of applying for or receiving VA service-connected disability are eligible

Más betegség

• Moderate to severe cognitive impairment (Montreal Cognitive Assessment score <16/30)
• Poor pre-stroke baseline function of a modified Rankin score >2
• Current diagnosis of DSM-5-defined bipolar disorder I, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or major depressive disorder with psychotic features (MINI)
• Diagnosis of moderate or severe substance use disorder (except for caffeine and nicotine) during the preceding 3 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 during the study
• History of moderate or severe TBI as defined by the Ohio State University TBI Identification Method
  • Based on investigator's clinical judgment, history of mild TBI is not excluded
• Severe allergic reaction, bronchospasm, or hypersensitivity to any MPH formulation.
• Current enrollment in another intervention trial for PTSD or stroke
• Persons imprisoned, diagnosed with terminal illness, or require surrogate for consent

Laborértékek

• Any clinically significant, uncontrolled, or medical/surgical condition or laboratory abnormality that would contraindicate use of MPH (see Human Subjects section)

Egyéb

• Presence of any standard MRI contraindications

• Male or female Veteran of US military; signed informed consent
• Criterion A Index Trauma(s) resulting in PTSD occurred during adulthood prior to stroke
• CAPS-5 past week total score =23 at baseline visit
• Willing to refrain from antipsychotics, mood stabilizers, stimulants, and any formulation of MPH
• First-ever symptomatic ischemic stroke radiologically verified, occurring within past 1-12 months
• Females of child-bearing potential (i.e. not postmenopausal or surgically sterile) 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