The Efficacy of a Pharmacological Treatment (Reboxetine Plus Ritalin) Versus Dog-Assisted Therapy in PTSD

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Haifa

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

Qualifiers

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

Treatments tested in this trial

  • methylphenidate (Ritalin®)
  • Reboxetine
  • Placebo
  • Placebo
  • Dog-Assisted Therapy
  • Occupational Therapy

Treatment groups

160 Participants
are divided into 4 treatment groups

Sponsors and collaborators