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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 60
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Israel
Emek Medical Center
RECRUITING
Afula
University of Haifa
RECRUITING
Haifa
Lev HaSharon Mental Health Center
RECRUITING
Netanya
Contact Information
Primary
Avi Avital, PhD
avitalavi@hotmail.com
+972-4-8420-364
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 53
Treatments
Experimental: Treatment with Reboxetine and Methylphenidate
During the first 3 weeks of the study, subjects in the active treatment group will take reboxetine at a dose of 4mgper day, with the instructions to start at 2mg per day for 3 days and then increase the dosage to 4mg per day for 26 days, i.e. until completion of the study.~On day 22 of the study, the patients will take the first dosage of10mg Ritalin or a placebo, and remain in the clinic for 2 hours to guard safety and guidance during possible occurrence of side effects such as anxiety, palpitations, etc. During the observation time in the clinic, 6 Ritalin IR 10mg and 3 Reboxetine 4mg pills will be handed out to the participants. These pills will be taken at the responsibility of the subject at8:00 AM (Ritalin and Reboxetine) and at noon (Ritalin only) at the following three days.
Placebo_comparator: Treatment with Placebo
The patients will take placebos according to the medication schedule of the treatment group.
Related Therapeutic Areas
Sponsors
Leads: University of Haifa

This content was sourced from clinicaltrials.gov