Posttraumatic Stress DisorderPhase 2NCT05133804
Efficacy of Reboxetine and Methylphenidate Treatment on Attentional, Sensory and Emotional Dysregulation in Adults With PTSD
A Phase 2 study testing Methylphenidate and Reboxetine in people with Posttraumatic Stress Disorder, run by University of Haifa at 3 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Methylphenidate and Reboxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 3 sitesIsrael
- Study dates
- 1 Jun 2022to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
- severe disease that is a threat to life, e.g. acute myocardial infarction, respiratory failure, or cancer,
- nervous system impairment, e.g. multiple sclerosis, Alzheimer's disease, Parkinson's disease, epilepsy, or stroke,
Show all 14Show fewer
- previous or current severe traumatic brain injury,
- glaucoma,
- impaired hearing,
- pregnancy or breastfeeding during study inclusion,
- active substance dependency including regular use of medical cannabis,
- use of steroid medication in the two months prior to study conductance,
- use of medication that may affect the function of the central nervous system,
- failure to complete all research steps
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel3 sites, 3 recruiting
- Recruiting
Emek Medical Center
Afula
Tsipi Milman, MD, tsipimi@clalit.org.il
- Recruiting
University of Haifa
Haifa
Avi Avital, PhD, +972-4-8420-364, avitalavi@hotmail.com
Batya Engel-Yeger, PhD, +972-4-828-8387, bengel@univ.haifa.ac.il
- Recruiting
Lev HaSharon Mental Health Center
Netanya
Inbal Brenner, MD, +972 9 8981111, inbalbrenner@gmail.com
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Methylphenidate, Reboxetine, Placebo
- Keywords
- Posttraumatic Stress Disorder, Attention Deficit, Sensory Processing, Emotion Regulation, Methylphenidate, Reboxetine, Randomized Controlled Trial, Electroencephalogram, Functional near-infrared spectroscopy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Attention Deficit Disorder with Hyperactivity, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Ritalin
Ritalin 10mg
ReboxetineDrug
Reboxetine 4mg
PlaceboDrug
Also called Placebo matched to Reboxetine
Placebo matched to Reboxetine
PlaceboDrug
Also called Placebo matched to Ritalin
Placebo matched to Ritalin
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Reboxetine and Methylphenidate | Experimental | 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. Receives: Drug: Methylphenidate; Drug: Reboxetine |
| Treatment with Placebo | Placebo comparator | The patients will take placebos according to the medication schedule of the treatment group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 and day 26
Secondary outcomes (10)
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.
Measured: 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.
Measured: Day 1 and day 26
Electroencephalography (EEG)
Electrical brain activity, measured through event-related potentials (ERP)
Measured: Day 1, day 21 and day 26
Functional near-infrared spectroscopy (fNIRS)
Cortical hemodynamic activity, measured through concentrations of oxygenated and deoxygenated hemoglobin.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 and day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Jun 2022
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into two groups: either treatment with medication or treatment with placebo. In addition, within each group patients will be randomized into a group for EEG recording and a group for fNIRS recording. This is a non-interventional randomization.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avi Avital, University of Haifa
- Investigators
- Avi Avital, PhD, Principal investigator, University of HaifaBatya Engel-Yeger, PhD, Principal investigator, University of HaifaInbal Brenner, MD, Principal investigator, Lev HaSharon Mental Health CenterTsipi Milman, MD, Principal investigator, Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133804
- Sponsor's protocol ID
- LH9/2019
- Status last verified
- Aug 2026
- First submitted
- 4 Oct 2021
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aga-Mizrachi S, Cymerblit-Sabba A, Gurman O, Balan A, Shwam G, Deshe R, Miller L, Gorodetsky N, Heinrich N, Tzezana O, Zubedat S, Grinstein D, Avital A. Methylphenidate and desipramine combined treatment improves PTSD symptomatology in a rat model. Transl Psychiatry. 2014 Sep 23;4(9):e447. doi: 10.1038/tp.2014.82.
PubMed 25247592McAllister TW, Zafonte R, Jain S, Flashman LA, George MS, Grant GA, He F, Lohr JB, Andaluz N, Summerall L, Paulus MP, Raman R, Stein MB. Randomized Placebo-Controlled Trial of Methylphenidate or Galantamine for Persistent Emotional and Cognitive Symptoms Associated with PTSD and/or Traumatic Brain Injury. Neuropsychopharmacology. 2016 Apr;41(5):1191-8. doi: 10.1038/npp.2015.282. Epub 2015 Sep 11.
PubMed 26361060
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05133804
- Acronym / sponsor ID
- LH9/2019
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, Attention Deficit, Sensory Processing, Emotion Regulation, Methylphenidate, Reboxetine, Randomized Controlled Trial, Electroencephalogram
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized into two groups: either treatment with medication or treatment with placebo. In addition, within each group patients will be randomized into a group for EEG recording and a group for fNIRS recording. This is a non-interventional randomization.
| Arm | Type | Receives |
|---|---|---|
| Treatment with Reboxetine and Methylphenidate | Experimental | Drug: Methylphenidate, Drug: ReboxetineDuring 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. |
| Treatment with Placebo | Placebo comparator | Drug: PlaceboThe patients will take placebos according to the medication schedule of the treatment group. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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,
- severe disease that is a threat to life, e.g. acute myocardial infarction, respiratory failure, or cancer,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateAlso: RitalinRitalin 10mg | Drug | Treatment with Reboxetine and Methylphenidate |
| ReboxetineReboxetine 4mg | Drug | Treatment with Reboxetine and Methylphenidate |
| PlaceboAlso: Placebo matched to ReboxetinePlacebo matched to Reboxetine | Drug | Treatment with Placebo |
| PlaceboAlso: Placebo matched to RitalinPlacebo matched to Ritalin | Drug | Treatment with Placebo |
Primary outcome
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)
Time frame: Day 1 and day 26
PTSD symptom severity score. Total of 56 questions. Minimum score 0, maximum score 80. A higher score reflects a worse outcome.
10 secondary outcomes
Posttraumatic Stress Disorder Symptom Scale (PSS-SR5)
Time frame: Day 1 and day 26
Conner's Adult ADHD Rating Scales - Self Report: short version (CAARS-S:S)
Time frame: Day 1 and day 26
Electroencephalography (EEG)
Time frame: Day 1, day 21 and day 26
Functional near-infrared spectroscopy (fNIRS)
Time frame: Day 1, day 21 and day 26
Electrodermal Activity (EDA)
Time frame: Day 1, day 21 and day 26
Auditory Sustained Attention Test (ASAT)
Time frame: Day 1, day 21 and day 26
Adolescent/Adult Sensory Profile Questionnaire (AASP)
Time frame: Day 1 and day 26
Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Time frame: Day 1 and day 26
Daily Life Questionnaire (DLQ)
Time frame: Day 1 and day 26
World Health Organization Quality of Life Questionnaire - BREF (WHOQOL-BREF)
Time frame: Day 1 and day 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 25247592Aga-Mizrachi S, Cymerblit-Sabba A, Gurman O, Balan A, Shwam G, Deshe R, Miller L, Gorodetsky N, Heinrich N, Tzezana O, Zubedat S, Grinstein D, Avital A. Methylphenidate and desipramine combined treatment improves PTSD symptomatology in a rat model. Transl Psychiatry. 2014 Sep 23;4(9):e447. doi: 10.1038/tp.2014.82.
- Background: PubMed 26361060McAllister TW, Zafonte R, Jain S, Flashman LA, George MS, Grant GA, He F, Lohr JB, Andaluz N, Summerall L, Paulus MP, Raman R, Stein MB. Randomized Placebo-Controlled Trial of Methylphenidate or Galantamine for Persistent Emotional and Cognitive Symptoms Associated with PTSD and/or Traumatic Brain Injury. Neuropsychopharmacology. 2016 Apr;41(5):1191-8. doi: 10.1038/npp.2015.282. Epub 2015 Sep 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Avi Avital, PhD principal investigator
University of Haifa
Batya Engel-Yeger, PhD principal investigator
University of Haifa
Inbal Brenner, MD principal investigator
Lev HaSharon Mental Health Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylphenidate and Reboxetine in people with Posttraumatic Stress Disorder, run by University of Haifa at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avi Avital, PhD (+972-4-8420-364, avitalavi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Day 1 and day 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05133804, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.