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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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,
Trial design
Parallel
Treatments tested in this trial
Methylphenidate
DrugRitalin 10mg
Reboxetine
DrugReboxetine 4mg
Placebo
DrugPlacebo matched to Reboxetine
Placebo
DrugPlacebo matched to Ritalin
Treatment groups
Trial outcomes
Primary outcomes
Change in Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual (DSM)-5 (CAPS-5) between baseline score (before treatment) and score on day 26 (after treatment)
PTSD symptom severity score. Total of 56 questions. Minimum score 0, maximum score 80. A higher score reflects a worse outcome.
Secondary outcomes
Posttraumatic Stress Disorder Symptom Scale (PSS-SR5)
PTSD symptom severity score. Total of 24 questions. Minimum score 0, maximum score 80. A higher score reflects a worse outcome.
Conner's Adult ADHD Rating Scales - Self Report: short version (CAARS-S:S)
ADHD index score. Total of 26 questions. Minimum score 26, maximum score 78. A higher score reflects a worse outcome.
Electroencephalography (EEG)
Electrical brain activity, measured through event-related potentials (ERP)
Functional near-infrared spectroscopy (fNIRS)
Cortical hemodynamic activity, measured through concentrations of oxygenated and deoxygenated hemoglobin.
Sponsors and contacts
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