Efficacy of Reboxetine and Methylphenidate Treatment on Attentional, Sensory and Emotional Dysregulation in Adults With PTSD
Posttraumatic Stress Disorder
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Attention Deficit, Sensory Processing, Emotion Regulation, Methylphenidate, Reboxetine, Randomized Controlled Trial, Electroencephalogram, Functional near-infrared spectroscopy
Eligibility Criteria
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:
- comorbid major psychiatric disorder, e.g. psychotic disorder, unipolar or bipolar disorder, borderline personality disorder, or active suicidal ideation,
- ADHD diagnosis,
- significant or severe systematic disease that limits normal activity, e.g. autoimmune disease, AIDS or renal failure,
- cardiovascular disease, e.g. hypertension, atrioventricular (AV) block, bradycardia, or conduction disorder,
- severe disease that is a threat to life, e.g. acute myocardial infarction, respiratory failure, or cancer,
- nervous system impairment, e.g. multiple sclerosis, Alzheimer's disease, Parkinson's disease, epilepsy, or stroke,
- previous or current severe traumatic brain injury,
- glaucoma,
- impaired hearing,
- pregnancy or breastfeeding during study inclusion,
- active substance dependency including regular use of medical cannabis,
- use of steroid medication in the two months prior to study conductance,
- use of medication that may affect the function of the central nervous system,
- failure to complete all research steps
Sites / Locations
- Emek Medical CenterRecruiting
- University of HaifaRecruiting
- Lev HaSharon Mental Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Treatment with Reboxetine and Methylphenidate
Treatment with Placebo
During the first 3 weeks of the study, subjects in the active treatment group will take reboxetine at a dose of 4mgper day, with the instructions to start at 2mg per day for 3 days and then increase the dosage to 4mg per day for 26 days, i.e. until completion of the study. On day 22 of the study, the patients will take the first dosage of10mg Ritalin or a placebo, and remain in the clinic for 2 hours to guard safety and guidance during possible occurrence of side effects such as anxiety, palpitations, etc. During the observation time in the clinic, 6 Ritalin IR 10mg and 3 Reboxetine 4mg pills will be handed out to the participants. These pills will be taken at the responsibility of the subject at8:00 AM (Ritalin and Reboxetine) and at noon (Ritalin only) at the following three days.
The patients will take placebos according to the medication schedule of the treatment group.