Actively Recruiting

Phase 2
Age: 20Years - 60Years
All Genders
Healthy Volunteers
NCT05133804

Efficacy of Reboxetine and Methylphenidate Treatment on Attentional, Sensory and Emotional Dysregulation in Adults With PTSD

Led by University of Haifa · Updated on 2025-03-27

53

Participants Needed

3

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Up-to-date, no studies have examined the attentional, sensory and emotional processing (difficulties) among patients diagnosed with Posttraumatic Stress Disorder (PTSD). In addition, the efficiency of drug treatments that focus on the noradrenergic and dopaminergic, and thus influence attention processing and PTSD symptoms through these pathways, have only briefly been investigated. There is well-established and long-standing evidence for the involvement of dopamine and noradrenaline in attentional function. This previously led to an investigation by the investigator's research lab in which the investigators hypothesized the involvement of an attentional disorder would influence PTSD symptoms in a rat model. Based on these results, the current study aims to characterize attentional deficits in patients with PTSD, as well as the correlation between attention, emotional regulation and sensory processing. The investigators do this partially by conducting a case-control study and through a subsequent double-blind RCT (with only the cases). The patients will be either treated with reboxetine + methylphenidate or placebo.

CONDITIONS

Official Title

Efficacy of Reboxetine and Methylphenidate Treatment on Attentional, Sensory and Emotional Dysregulation in Adults With PTSD

Who Can Participate

Age: 20Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with PTSD according to DSM-IV or DSM-5 criteria
  • Currently treated at the outpatient facilities of Lev HaSharon Netanya Adult Clinic
  • Aged between 20 and 60 years
  • PTSD diagnosis made at least one month before study inclusion
  • No current re-exposure to the traumatic event
  • Any psychotropic drug therapy is at a stable dose for at least one month before the study
Not Eligible

You will not qualify if you...

  • Comorbid major psychiatric disorders such as psychotic disorder, unipolar or bipolar disorder, borderline personality disorder, or active suicidal ideation
  • Diagnosis of ADHD
  • Significant or severe systemic diseases limiting normal activity, e.g., autoimmune disease, AIDS, or renal failure
  • Cardiovascular diseases including hypertension, AV block, bradycardia, or conduction disorders
  • Severe life-threatening diseases such as acute myocardial infarction, respiratory failure, or cancer
  • Nervous system impairments like multiple sclerosis, Alzheimer's disease, Parkinson's disease, epilepsy, or stroke
  • Previous or current severe traumatic brain injury
  • Glaucoma
  • Impaired hearing
  • Pregnancy or breastfeeding at study inclusion
  • Active substance dependency including regular medical cannabis use
  • Use of steroid medication within two months prior to study
  • Use of medications affecting central nervous system function
  • Failure to complete all research steps

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Emek Medical Center

Afula, Israel

Actively Recruiting

2

University of Haifa

Haifa, Israel

Actively Recruiting

3

Lev HaSharon Mental Health Center

Netanya, Israel

Actively Recruiting

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Research Team

A

Avi Avital, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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