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Efficacy of Reboxetine and Methylphenidate Treatment on Attentional, Sensory and Emotional Dysregulation in Adults With PTSD

RecruitingPhase 2Ages 20 Years - 60 YearsAllUniversity of Haifa
NCT05133804 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Up-to-date, no studies have examined the attentional, sensory and emotional processing (difficulties) among patients diagnosed with Posttraumatic Stress Disorder (PTSD). In addition, the efficiency of drug treatments that focus on the noradrenergic and dopaminergic, and thus influence attention processing and PTSD symptoms through these pathways, have only briefly been investigated. There is well-established and long-standing evidence for the involvement of dopamine and noradrenaline in attentional function. This previously led to an investigation by the investigator's research lab in which the investigators hypothesized the involvement of an attentional disorder would influence PTSD symptoms in a rat model. Based on these results, the current study aims to characterize attentional deficits in patients with PTSD, as well as the correlation between attention, emotional regulation and sens

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📋 Eligibility rules (as published)
Inclusion Criteria: * diagnosed with PTSD according to DSM-IV or DSM-5 criteria * current treatment at the outpatient facilities of Lev HaSharon Netanya Adult Clin * age between 20 and 60 years * PTSD diagnosis at least one month prior to study inclusion * no present-day re-exposure to the traumatic event * any psychotropic drug therapy that is being administered must be at a fixed dose for at least one month prior to the study conductance Exclusion Criteria: 1. comorbid major psychiatric disorder, e.g. psychotic disorder, unipolar or bipolar disorder, borderline personality disorder, or active suicidal ideation, 2. ADHD diagnosis, 3. significant or severe systematic disease that limits normal activity, e.g. autoimmune disease, AIDS or renal failure, 4. cardiovascular disease, e.g. hypertension, atrioventricular (AV) block, bradycardia, or conduction disorder, 5. severe disease that is a threat to life, e.g. acute myocardial infarction, respiratory failure, or cancer, 6. nervous system impairment, e.g. multiple sclerosis, Alzheimer's disease, Parkinson's disease, epilepsy, or stroke, 7. previous or current severe traumatic brain injury, 8. glaucoma, 9. impaired hearing, 10. pregnancy or breastfeeding during study inclusion, 11. active substance dependency including regular use of medical cannabis, 12. use of steroid medication in the two months prior to study conductance, 13. use of medication that may affect the function of the central nervous system, 14. failure to complete all research steps
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What it tests

  • Methylphenidate
  • Reboxetine
  • Placebo
  • Placebo
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Where

3 sites
Emek Medical Center
Afula, Israel
University of Haifa
Haifa, Israel
Lev HaSharon Mental Health Center
Netanya, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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