A Phase 2 interventional study of Methylphenidate and Reboxetine in Posttraumatic Stress Disorder, sponsored by University of Haifa. Recruiting at 3 sites in Israel. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by University of Haifa · Phase 2, Interventional, and Treatment
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.
Posttraumatic stress disorder (PTSD) is a highly impairing psychiatric disorder, characterized by re-experiencing, avoidance behaviour, emotional numbing, and hyperarousal after traumatic exposure. Current treatments mainly focus on non-cognitive symptoms and are only partially effective: one third of PTSD patients will find symptoms to be chronic and progressive; highly impacting daily function and quality of life. Arising evidence suggests a correlation between impaired attention, sensory dysfunction, and PTSD symptoms. Thus, the importance of combined treatment, focused on concentration difficulties as often found PTSD, has been suggested. Two suggested leads are reboxetine and methylphenidate.
Hypothesising that impaired attentional and sensory processing induces re-experiencing with avoidance and hyperarousal as coping strategies, the investigators aim to elucidate the neuro-dysregulation characteristics of each of the PTSD symptoms, with focus on attention, executive function and sensory processing, and relate to their implications on daily life function, following a novel combined treatment strategy of reboxetine and methylphenidate (Ritalin).
A case-control study will be conducted, including 53adult patients with PTSD and 53 matched healthy controls. First, a baseline measure will be performed amongst all participants to create a population profile. Then, patients will be randomised into an active treatment group (n=27) and a placebo group (n=26) for a double-blind randomized controlled trial, investigating the effect of a 3-week treatment with reboxetine 4mg per day and a one-week addition of Ritalin 10mg twice a day.
This research will include established and innovative neurophysiological measures and questionnaires. A PTSD symptom profile will be created combining the Clinician-Administered Posttraumatic Stress Disorder Scale and Posttraumatic Stress Disorder Symptom Scale. Brain activity will be measured using functional near-infrared spectroscopy (fNIR) or electroencephalography, with the Auditory Sustained Attention Test (ASAT) and Electrodermal Activity (EDA). Together with the Conners' Adult Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale - Short Version, the ASAT and EDA will create an attentional profile. Furthermore, a sensory profile consisting of the Adolescent/Adult Sensory Profile Questionnaire, and an executive function profile measured with the Behavior Rating Inventory of Executive Function will be created. Finally, in order to relate to individual experiences in real-life context, this research measures activities through the Daily Living Questionnaire and quality of life with the World Health Organization Quality of Life Instrument.
Using a translational research paradigm, this research is one of the first to investigate neuro-dysregulation in PTSD with a focus on sensory processing and executive function, with emphasis on attention and behaviour. It is also the first research to integrate the fNIR with the ASAT and EDA, thus contributing to the technological advancing of clinical research. This research will gather innovative data that may offer new explanations of PTSD symptoms and allow for further development of treatment interventions needed to reduce the burden of disease and optimise quality of life.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 53 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →University of Haifa is the lead sponsor of 105 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Methylphenidate · Drug: Reboxetine
The patients will take placebos according to the medication schedule of the treatment group.
Drug: Placebo
Ritalin 10mg
Also known as: Ritalin
Reboxetine 4mg
Placebo matched to Reboxetine
Also known as: Placebo matched to Reboxetine
Placebo matched to Ritalin
Also known as: Placebo matched to Ritalin
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
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
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
Electroencephalography (EEG)
Electrical brain activity, measured through event-related potentials (ERP)
Time frame: Day 1, day 21 and day 26
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
Electrodermal Activity (EDA)
Electrodermal activity, measured through sweat secretion on digit 2 and digit 4 of right hand.
Time frame: Day 1, day 21 and day 26
Auditory Sustained Attention Test (ASAT)
Pre-pulse inhibition, measured through the eyeblink reflex at the level of the musculus orbicularis oculi 1cm below the pupil.
Time frame: Day 1, day 21 and day 26
Adolescent/Adult Sensory Profile Questionnaire (AASP)
Sensory profile. Total of 60 questions. Minimum score 60, maximum score 300. A higher score reflects a worse outcome.
Time frame: Day 1 and day 26
Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Global executive composite. Total of 75 questions. Minimum score 75, maximum score 225. A higher score reflects a worse outcome.
Time frame: Day 1 and day 26
Daily Life Questionnaire (DLQ)
Daily life limitations. Total of 59 questions. Minimum score 28, maximum score 112. A higher score reflects a worse outcome.
Time frame: Day 1 and day 26
World Health Organization Quality of Life Questionnaire - BREF (WHOQOL-BREF)
Quality of Life. Total of 26 questions. Minimum score 24, maximum score 120. A higher score reflects a better outcome.
Time frame: Day 1 and day 26
Plan to share: No
Started Jun 2022 (actual). Primary completion is estimated for Oct 2026, 52 months after the start.
Of 87 non-industry phase 2 interventional studies under Stress Disorders, Post-Traumatic, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 59. This study's planned 52 months is above that.
Counting every sponsor, half of 118 studies reached it within 38 months; a quarter within 23 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Methylphenidate · Reboxetine
Stress Disorders, Post-Traumatic →