RecruitingPhase 2NCT05133804

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


Sponsor

University of Haifa

Enrollment

53 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 20 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether two medications — reboxetine (a norepinephrine reuptake inhibitor) and methylphenidate (commonly known as Ritalin) — can help improve attention, emotional regulation, and sensory problems in adults with PTSD. **You may be eligible if...** - You have been diagnosed with PTSD (by DSM-IV or DSM-5 criteria) - You are between 20 and 60 years old - You are currently receiving outpatient care at a participating clinic - Your PTSD was diagnosed at least one month ago - If you're on psychiatric medications, the dose has been stable for at least one month **You may NOT be eligible if...** - You have another major psychiatric condition (such as psychosis, bipolar disorder, or active substance use) - You are currently re-exposed to your traumatic event Talk to your doctor to see if this trial is right for you.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMethylphenidate

Ritalin 10mg

DRUGReboxetine

Reboxetine 4mg

DRUGPlacebo

Placebo matched to Reboxetine

DRUGPlacebo

Placebo matched to Ritalin


Locations(3)

Emek Medical Center

Afula, Israel

University of Haifa

Haifa, Israel

Lev HaSharon Mental Health Center

Netanya, Israel

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05133804


Related Trials