About this trial
Posttraumatic stress disorder (PTSD) is a chronic and often treatment-resistant psychiatric condition that emerges following exposure to trauma and is characterized by intrusive thoughts, emotional dysregulation, and cognitive impairments. In Israel, the prevalence of PTSD has increased significantly in the aftermath of the October 7, 2023 terror attacks, emphasizing the urgent need for more effective, accessible, and personalized interventions.
Existing treatments, such as trauma-focused CBT and SSRIs, remain only partially effective, with side effects that reduce adherence and limit long-term recovery. The proposed randomized controlled trial will assess and compare two promising treatment modalities: (i) a new pharmacological combination of reboxetine and methylphenidate, designed to enhance noradrenergic and dopaminergic pathways involved in attention and emotional regulation, and (ii) dog-assisted therapy (DAT), a non-pharmacological, group-based intervention shown to reduce PTSD symptoms and improve functioning. One hundred sixty adults with PTSD will be randomized into four groups: pharmacological treatment, placebo, DAT, or occupational therapy. The study will use validated clinical scales (CAPS-5, GAD-7, CAARS, DLQ, WHOQOLBREF) alongside neurophysiological tools (EEG, EDA, ASAT-based EMG). Data will feed into a machine-learning model to identify predictors of treatment response and support the development of personalized, neurobiologically informed approaches.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age between 18 and 70 years,
diagnosed with PTSD according to DSM-IV or DSM-5 criteria,
any psychotropic drug therapy that is being administered must be at a fixed dose for at least one month prior to the study initiation.
Disqualifiers
any health condition for which the use of reboxetine or methylphenidate is contraindicated,
comorbidity with major psychiatric disorder,
significant/active cardiovascular disease,
previous or current severe traumatic brain injury,
Trial design
Parallel
Treatments tested in this trial
methylphenidate (Ritalin®)
DrugRitalin 10mg
Reboxetine
DrugReboxetine 4mg
Placebo
DrugPlacebo matched to Reboxetine
Placebo
DrugPlacebo matched to Ritalin
Dog-Assisted Therapy
BehavioralDog-Assisted Therapy
Occupational Therapy
BehavioralOccupational Therapy
Treatment groups
Trial outcomes
Primary outcomes
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
PTSD symptom severity score. Total of 56 questions. Minimum score 0, maximum score 80. A higher score reflects a worse outcome.
Secondary outcomes
General Anxiety Disorder-7 (GAD-7)
Self-report scale to evaluate general anxiety symptoms.
Conners' Adult ADHD Rating Scales (CAARS)
Measures attentional and executive function impairments commonly comorbid with PTSD.
Daily Life Questionnaire (DLQ)
Assesses the impact of symptoms on functional capacity in everyday contexts.
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
A comprehensive index of physical, psychological, and social quality of life domains.
Sponsors and contacts
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