Effect of Reboxetine and Methylphenidate on Attention and Emotion in PTSD

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

This study is testing if the medications reboxetine and methylphenidate can help improve attention and emotional control in adults with PTSD.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Ages: 20 Years to 60 Years
• Sex: All
• Sponsor: University of Haifa (other)
• Locations: 3 sites (Afula and 2 other locations)
• Trial ID: NCT05133804 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of reboxetine and methylphenidate on attentional, sensory, and emotional dysregulation in adults diagnosed with Posttraumatic Stress Disorder (PTSD). It aims to characterize the relationship between attention deficits and PTSD symptoms through a case-control design involving 53 patients with PTSD and 53 matched healthy controls. Participants will undergo baseline assessments before being randomized into either an active treatment group or a placebo group in a double-blind manner. The study seeks to explore how these medications may improve attention and emotional regulation in individuals suffering from PTSD.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 20 to 60 who have been diagnosed with PTSD and are currently receiving outpatient treatment.

Not a fit: Patients with comorbid major psychiatric disorders or those with ADHD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with PTSD, enhancing their attention and emotional regulation.

How similar studies have performed: While there is emerging evidence regarding the relationship between attention and PTSD, this specific combination of treatments has not been extensively tested, making it a novel approach.

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

Where this trial is running

Afula and 2 other locations

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

Study contacts

• Principal investigator: Avi Avital, PhD — University of Haifa
• Study coordinator: Avi Avital, PhD

Conditions: Posttraumatic Stress Disorder, Attention Deficit, Sensory Processing, Emotion Regulation, Methylphenidate, Reboxetine, Randomized Controlled Trial, Electroencephalogram