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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • methylphenidate (Ritalin®)

    Drug

    Ritalin 10mg

  • Reboxetine

    Drug

    Reboxetine 4mg

  • Placebo

    Drug

    Placebo matched to Reboxetine

  • Placebo

    Drug

    Placebo matched to Ritalin

  • Dog-Assisted Therapy

    Behavioral

    Dog-Assisted Therapy

  • Occupational Therapy

    Behavioral

    Occupational Therapy

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: Treatment with Reboxetine and MethylphenidateExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Dog-Assisted TherapyExperimental treatment 1 intervention
Group D: Occupational TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Secondary outcomes

1

General Anxiety Disorder-7 (GAD-7)

Self-report scale to evaluate general anxiety symptoms.

Time frame
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.
2

Conners' Adult ADHD Rating Scales (CAARS)

Measures attentional and executive function impairments commonly comorbid with PTSD.

Time frame
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.
3

Daily Life Questionnaire (DLQ)

Assesses the impact of symptoms on functional capacity in everyday contexts.

Time frame
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.
4

World Health Organization Quality of Life - BREF (WHOQOL-BREF)

A comprehensive index of physical, psychological, and social quality of life domains.

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.