RecruitingPhase 2NCT07771530

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

Evaluating the Efficacies of an Innovative Pharmacological Treatment (Reboxetine Plus Ritalin) Versus Dog-Assisted Therapy in PTSD: A Randomized Controlled Trial


Sponsor

University of Haifa

Enrollment

160 participants

Start Date

Aug 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Dog-Assisted Therapy, a behavioral approach called Occupational Therapy, and others for people with ptsd and posttraumatic stress disorder. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmethylphenidate (Ritalin®)

Ritalin 10mg

DRUGReboxetine

Reboxetine 4mg

DRUGPlacebo

Placebo matched to Reboxetine

DRUGPlacebo

Placebo matched to Ritalin

BEHAVIORALDog-Assisted Therapy

Dog-Assisted Therapy

BEHAVIORALOccupational Therapy

Occupational Therapy


Locations(1)

University of Haifa

Haifa, Israel

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NCT07771530


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