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

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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 our lab in which we 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. We 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Haifa
• Treatments: Methylphenidate; Reboxetine

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, 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