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RECRUITING
NCT05133804
PHASE2

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

Sponsor: University of Haifa

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2022-06-01

Completion Date

2025-12-01

Last Updated

2025-03-27

Healthy Volunteers

Yes

Interventions

DRUG

Methylphenidate

Ritalin 10mg

DRUG

Reboxetine

Reboxetine 4mg

DRUG

Placebo

Placebo matched to Reboxetine

DRUG

Placebo

Placebo matched to Ritalin

Locations (3)

Emek Medical Center

Afula, Israel

University of Haifa

Haifa, Israel

Lev HaSharon Mental Health Center

Netanya, Israel