drugset / Trial / NCT05133804

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

NCT05133804

Phase 2 Recruiting 53 enrolled University of Haifa
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2022-06-01
Primary completion
2025-07-01
Completion
2025-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylphenidate Small molecule 10 mg
Subject Reboxetine Unknown 4 mg