RECRUITINGPhase 2INTERVENTIONAL

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

The Relation Between Attentional, Sensory and Emotional Dysregulation in Adults With Posttraumatic Stress Disorder: a Double-blind, Placebo-controlled Randomized Controlled Trial of the Combined Treatment With Reboxetine and Methylphenidate

About This Trial

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 sensory processing. The investigators do this partially by conducting a case-control study and through a subsequent double-blind RCT (with only the cases). The patients will be either treated with reboxetine + methylphenidate or placebo.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: 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 conditions (where your immune system attacks your own body), 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Methylphenidate

Ritalin 10mg

DRUG

Reboxetine

Reboxetine 4mg

DRUG

Placebo

Placebo matched to Reboxetine

DRUG

Placebo

Placebo matched to Ritalin

Locations (3)

Emek Medical Center

Afula, Israel

University of Haifa

Haifa, Israel

Lev HaSharon Mental Health Center

Netanya, Israel