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

Condition(s) studied

Investigational drug(s) / intervention(s)

methylphenidate (Ritalin®): Ritalin 10mg

Reboxetine: Reboxetine 4mg

Placebo: Placebo matched to Reboxetine

Placebo: Placebo matched to Ritalin

Dog-Assisted Therapy: Dog-Assisted Therapy

Occupational Therapy: Occupational Therapy

Study summary

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

Primary outcome measure(s)

• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) — Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
  PTSD symptom severity score. Total of 56 questions. Minimum score 0, maximum score 80. A higher score reflects a worse outcome.

Trial sites (1)

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