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

NCT ID
NCT05133804
Registry status
Recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
University of Haifa
Conditions
Posttraumatic Stress Disorder

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: The Relation Between Attentional, Sensory and Emotional Dysregulation in Adults With Posttraumatic Stress Disorder: a Double-blind, Placebo-controlled Randomized Controlled Trial of the Combined Treatment With Reboxetine and Methylphenidate

Enrollment: 53 participants (Estimated).

What is being studied

  • Intervention: Acids, Carbocyclic
  • Intervention: Carboxylic Acids
  • Intervention: Heterocyclic Compounds
  • Intervention: Heterocyclic Compounds, 1-Ring
  • Drug: Methylphenidate
  • Intervention: Methylphenidate
  • Intervention: Morpholines
  • Intervention: Organic Chemicals
  • Intervention: Oxazines
  • Intervention: Phenylacetates
  • Intervention: Piperidines
  • Drug: Placebo
  • Intervention: Reboxetine
  • Drug: Reboxetine

Who may be eligible

Ages
20 Years to 60 Years
Sex
All
Healthy volunteers accepted
Yes

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * diagnosed with PTSD according to DSM-IV or DSM-5 criteria * current treatment at the outpatient facilities of Lev HaSharon Netanya Adult Clin * age between 20 and 60 years * PTSD diagnosis at least one month prior to study inclusion * no present-day re-exposure to the traumatic event * any psychotropic drug therapy that is being administered must be at a fixed dose for at least one month prior to the study conductance Exclusion Criteria: 1. comorbid major psychiatric disorder, e.g. psychotic disorder, unipolar or bipolar disorder, borderline personality disorder, or active suicidal ideation, 2. ADHD diagnosis, 3. significant or severe systematic disease that limits normal activity, e.g. autoimmune disease, AIDS or renal failure, 4. cardiovascular disease, e.g. hypertension, atrioventricular (AV) block, bradycardia, or conduction disorder, 5. severe disease that is a threat to life, e.g. acute myocardial infarction, respiratory failure, or cancer, 6. nervous system impairment, e.g. multiple sclerosis, Alzheimer's disease, Parkinson's disease, epilepsy, or stroke, 7. previous or current severe traumatic brain injury, 8. glaucoma, 9. impaired hearing, 10. pregnancy or breastfeeding during study inclusion, 11. active substance dependency including regular use of medical cannabis, 12. use of steroid medication in the two months prior to study conductance, 13. use of medication that may affect the function of the central nervous system, 14. failure to complete all research steps

Study locations

3 study locations are listed.

Recruiting site status is explicitly provided for 3 locations; 3 are listed as Recruiting.

Countries: Israel

Sample of listed locations

  • Emek Medical Center — Afula, Israel — Recruiting
  • University of Haifa — Haifa, Israel — Recruiting
  • Lev HaSharon Mental Health Center — Netanya, Israel — Recruiting

Study details

Start date
June 1, 2022
Primary completion date
October 1, 2026
Completion date
December 1, 2026
First posted
November 24, 2021

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT05133804
Registry last updated
August 11, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT05133804 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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