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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-60
SponsorUniversity of Haifa

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

comorbid major psychiatric disorder, e.g. psychotic disorder, unipolar or bipolar disorder, borderline personality disorder, or active suicidal ideation,

ADHD diagnosis,

significant or severe systematic disease that limits normal activity, e.g. autoimmune disease, AIDS or renal failure,

cardiovascular disease, e.g. hypertension, atrioventricular (AV) block, bradycardia, or conduction disorder,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methylphenidate

    Drug

    Ritalin 10mg

  • Reboxetine

    Drug

    Reboxetine 4mg

  • Placebo

    Drug

    Placebo matched to Reboxetine

  • Placebo

    Drug

    Placebo matched to Ritalin

Treatment groups

53 Participants
are divided into 2 treatment groups
Group A: Treatment with Reboxetine and MethylphenidateExperimental treatment 2 interventions
Group B: Treatment with PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual (DSM)-5 (CAPS-5) between baseline score (before treatment) and score on day 26 (after treatment)

PTSD symptom severity score. Total of 56 questions. Minimum score 0, maximum score 80. A higher score reflects a worse outcome.

Time frame
Day 1 and day 26

Secondary outcomes

1

Posttraumatic Stress Disorder Symptom Scale (PSS-SR5)

PTSD symptom severity score. Total of 24 questions. Minimum score 0, maximum score 80. A higher score reflects a worse outcome.

Time frame
Day 1 and day 26
2

Conner's Adult ADHD Rating Scales - Self Report: short version (CAARS-S:S)

ADHD index score. Total of 26 questions. Minimum score 26, maximum score 78. A higher score reflects a worse outcome.

Time frame
Day 1 and day 26
3

Electroencephalography (EEG)

Electrical brain activity, measured through event-related potentials (ERP)

Time frame
Day 1, day 21 and day 26
4

Functional near-infrared spectroscopy (fNIRS)

Cortical hemodynamic activity, measured through concentrations of oxygenated and deoxygenated hemoglobin.

Time frame
Day 1, day 21 and day 26

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.