PTSDPhase 2NCT07771530
The Efficacy of a Pharmacological Treatment (Reboxetine Plus Ritalin) Versus Dog-Assisted Therapy in PTSD
A Phase 2 study testing methylphenidate (Ritalin®), Reboxetine and Dog-Assisted Therapy in people with PTSD and Posttraumatic Stress Disorder, run by University of Haifa at 1 site in Israel.
Trial summary
Posttraumatic stress disorder (PTSD) is a chronic and often treatment-resistant psychiatric condition that emerges following exposure to trauma and is characterized by intrusive thoughts, emotional dysregulation, and cognitive impairments. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PTSD, Posttraumatic Stress Disorder
- What is being tested?
- methylphenidate (Ritalin®), Reboxetine and Dog-Assisted Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2026to 1 Aug 2028
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 70 years,
- diagnosed with PTSD according to DSM-IV or DSM-5 criteria,
- any psychotropic drug therapy that is being administered must be at a fixed dose for at least one month prior to the study initiation.
Who cannot join
- any health condition for which the use of reboxetine or methylphenidate is contraindicated,
- comorbidity with major psychiatric disorder,
- significant/active cardiovascular disease,
- previous or current severe traumatic brain injury,
- active substance dependency,
- participating in another treatment program for PTSD of any kind.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Janne L Punski-Hoogervorst, MD, PhD contact
Israel1 site, 1 recruiting
- Recruiting
University of Haifa
Haifa
Avi Avital, PhD, +972-4-8420-364, avitalavi@hotmail.com
Janne Punski-Hoogervorst, MD, PhD, jhoogerv@campus.haifa.ac.il
About this study
Official title: Evaluating the Efficacies of an Innovative Pharmacological Treatment (Reboxetine Plus Ritalin) Versus Dog-Assisted Therapy in PTSD: A Randomized Controlled Trial
Posttraumatic stress disorder (PTSD) is a chronic and often treatment-resistant psychiatric condition that emerges following exposure to trauma and is characterized by intrusive thoughts, emotional dysregulation, and cognitive impairments. In Israel, the prevalence of PTSD has increased significantly in the aftermath of the October 7, 2023 terror attacks, emphasizing the urgent need for more effective, accessible, and personalized interventions.
Existing treatments, such as trauma-focused CBT and SSRIs, remain only partially effective, with side effects that reduce adherence and limit long-term recovery. The proposed randomized controlled trial will assess and compare two promising treatment modalities: (i) a new pharmacological combination of reboxetine and methylphenidate, designed to enhance noradrenergic and dopaminergic pathways involved in attention and emotional regulation, and (ii) dog-assisted therapy (DAT), a non-pharmacological, group-based intervention shown to reduce PTSD symptoms and improve functioning. One hundred sixty adults with PTSD will be randomized into four groups: pharmacological treatment, placebo, DAT, or occupational therapy. The study will use validated clinical scales (CAPS-5, GAD-7, CAARS, DLQ, WHOQOLBREF) alongside neurophysiological tools (EEG, EDA, ASAT-based EMG). Data will feed into a machine-learning model to identify predictors of treatment response and support the development of personalized, neurobiologically informed approaches.
Read the detailed description
Posttraumatic Stress Disorder (PTSD) is a chronic and debilitating psychiatric condition characterized by intrusive memories, avoidance behaviors, hyperarousal, and emotional numbing. It is estimated that it affects 5.3% of the Israeli general population, though following the October 7, 2023 terror attacks, probable PTSD nearly doubled, from 16.2% to 29.8%, highlighting the urgent national need for effective and scalable PTSD interventions.
Given its high prevalence and physical and mental consequences, adequate treatment is needed. Current first-line therapies (TF-CBT and EMDR) are effective but are time-intensive, require specialized clinicians, and are not suitable for all patients. Pharmacological interventions, particularly SSRIs yield partial response rates (~60%) and often cause adherence-limiting side effects (e.g., major changes in body weight or loss of sexual drive). These limitations underscore the need for novel, tolerable, and mechanistically targeted therapies.
Arising evidence suggests a correlation between sensory dysfunction, impaired attention, and PTSD symptoms. The importance of combined treatment specifically targeting these difficulties has been suggested by us. Recent evidence suggests that PTSD involves dysregulation in both noradrenergic and dopaminergic systems, which play critical roles in attention, arousal, and emotional processing. Reboxetine, a norepinephrine reuptake inhibitor (NRI), and methylphenidate, a dopamine-enhancing psychostimulant, are hypothesized to have synergistic effects on PTSD-related cognitive and emotional deficits. Our lab's prior results suggest that this combination is safe, well-tolerated, and effective in reducing both clinician-rated PTSD symptoms, and neurophysiological dysregulations related to sensory gating and attention regulation, sensory processing, participation and quality of life.
Animal-assisted therapies, and DAT in particular, are increasingly recognized for their potential to reduce PTSD symptoms and improve emotional regulation. DAT programs for US veterans diagnosed with PTSD were found to be a helpful complementary or alternative treatment option for the veterans, demonstrating signs of meaningful improvements in mental and social health, lower PTSD symptoms severity and higher psychosocial functioning in veterans owning a psychiatric service dog, and positive correlation between Animal-assisted interventions (AAI) and a reduction of posttraumatic symptomatology. DAT programs have also been shown to foster resilience among veterans and their families. A meta-review found that DAT was as effective as traditional psychotherapy in symptom reduction. Our lab conducted a controlled study involving adolescents exposed to interpersonal trauma, showing significant improvement in PTSD symptoms, depression, and attentional regulation after a year-long dog training program (also on the dogs' attention and anxiety-like behavior).
Despite growing support for DAT and emerging evidence comparing DAT to psychotherapeutic interventions for PTSD symptomatology, no studies to date have directly compared pharmacological vs. animal-assisted therapy in PTSD. Moreover, there is a lack of objective, physiology-based tools to monitor treatment efficacy and guide individualized care. This study aims to bridge both gaps, combining a novel pharmacological strategy with neurophysiological diagnostics in a rigorously controlled, head-to-head RCT. Therefore, a four-arm randomized controlled trial (RCT) involving 160 adults diagnosed with PTSD, allocated to one of the following groups: 1. Combined pharmacological treatment (reboxetine + methylphenidate) 2. Pharmacological placebo control 3. Dog-assisted therapy (DAT) 4. Active control: Occupational therapy (OT) The pharmacological arm is double-blinded and placebo-controlled, while the DAT/OT arms are open-label, with participant preference and suitability guiding allocation. The study includes repeated measurements at multiple time points, combining subjective and objective outcomes.
- Conditions
- PTSD, Posttraumatic Stress Disorder
- Being tested
- methylphenidate (Ritalin®), Reboxetine, Placebo, Dog-Assisted Therapy, Occupational Therapy
- Keywords
- PTSD, Posttraumatic Stress Disorder, Reboxetine, Methylphenidate, Randomized Controlled Trial, Dog-assisted Therapy, Occupational Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidate (Ritalin®)Drug
Also called Ritalin
Ritalin 10mg
ReboxetineDrug
Reboxetine 4mg
PlaceboDrug
Placebo matched to Reboxetine
PlaceboDrug
Placebo matched to Ritalin
Dog-Assisted TherapyBehavioural
Dog-Assisted Therapy
Occupational TherapyBehavioural
Occupational Therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Reboxetine and Methylphenidate | Experimental | The trial starts with four days of treatment with 2mg of reboxetine every morning at 8 am. For the rest of the first three weeks, the participants will increase their dosage to 4mg every morning. During the fourth week, the participants will continue taking 4mg of reboxetine every morning at 8 am and additionally take 10mg of methylphenidate (or matching placebo) twice daily, i.e., in the morning at 8 am and at noon. Receives: Drug: methylphenidate (Ritalin®); Drug: Reboxetine |
| Placebo | Placebo comparator | The patients will take placebos according to the medication schedule of the treatment group. Receives: Drug: Placebo |
| Dog-Assisted Therapy | Experimental | . To encompass DAT protocol variability, it will be provided by certified rehabilitation farms in Israel and the US. The twenty-four DAT group therapy weekly sessions, over six months, will be conducted by licensed clinicians trained in occupational therapy, social work, psychology, and counseling, and are certified (diploma) to facilitate group therapy using therapy dogs. The clinicians have, on average, over four years of experience in providing services to people diagnosed with PTSD. Groups will typically have eight to fifteen human participants, depending on the rehabilitation farm. The DAT session's duration will last between fifty to sixty minutes. In generalization, session protocol will include: (i) defining a subject for each of the twenty-four AATx sessions, from which the clinicians will extract the therapeutic messages they would like to convey (e.g. regaining a sense of control, dealing with feelings of anger, guilt or shame, reducing feelings of alienation and distance); Receives: Behavioral: Dog-Assisted Therapy |
| Occupational Therapy | Active comparator | The occupational therapy schedule will roughly follow the same timeline as the dog-assisted therapy group. Therapy will be provided by licensed occupational therapists. Receives: Behavioral: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
PTSD symptom severity score. Total of 56 questions. Minimum score 0, maximum score 80. A higher score reflects a worse outcome.
Measured: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
Secondary outcomes (7)
General Anxiety Disorder-7 (GAD-7)
Self-report scale to evaluate general anxiety symptoms.
Measured: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
Conners' Adult ADHD Rating Scales (CAARS)
Measures attentional and executive function impairments commonly comorbid with PTSD.
Measured: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
Daily Life Questionnaire (DLQ)
Assesses the impact of symptoms on functional capacity in everyday contexts.
Measured: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
A comprehensive index of physical, psychological, and social quality of life domains.
Measured: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
Electroencephalography (EEG)
To assess resting-state brain activity (bandwidths delta, theta, alpha, beta, gamma) and ERPs associated with sensory gating, attention and emotional regulation (i.e., P50, N100, P200 and P300).
Measured: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
Electrodermal Activity (EDA)
To measure autonomic nervous system responses, including arousal and reactivity under baseline and taskrelated conditions.
Measured: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
Electromyography (EMG) - Auditory Sustained Attention Test (ASAT-based)
Developed in our lab (Maoz et al., 2021), this test quantifies startle reflex modulation in response to repeated auditory stimuli of varying intensities, reflecting disruptions in sustained attention and emotional reactivity
Measured: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Aug 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies 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 one of four groups: 1. Combined pharmacological treatment (reboxetine + methylphenidate) 2. Pharmacological placebo control 3. Dog-assisted therapy 4. Active control: Occupational therapy
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 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 Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771530
- Sponsor's protocol ID
- 102151
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Punski-Hoogervorst JL, Engel-Yeger B, Avital A. Attention deficits as a key player in the symptomatology of posttraumatic stress disorder: A review. J Neurosci Res. 2023 Jul;101(7):1068-1085. doi: 10.1002/jnr.25177. Epub 2023 Feb 20.
PubMed 36807926Maoz I, Zubedat S, Dolev T, Aga-Mizrachi S, Bloch B, Michaeli Y, Eshed Y, Grinstein D, Avital A. Dog training alleviates PTSD symptomatology by emotional and attentional regulation. Eur J Psychotraumatol. 2021 Nov 19;12(1):1995264. doi: 10.1080/20008198.2021.1995264. eCollection 2021.
PubMed 34868486McAllister 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 26361060Aga-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 25247592
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacies of an Innovative Pharmacological Treatment (Reboxetine Plus Ritalin) Versus Dog-Assisted Therapy in PTSD: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07771530
- Acronym / sponsor ID
- 102151
- Conditions
- PTSD, Posttraumatic Stress Disorder
- Keywords
- PTSD, Posttraumatic Stress Disorder, Reboxetine, Methylphenidate, Randomized Controlled Trial, Dog-assisted Therapy, Occupational Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 18 Aug 2026 (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.
Posttraumatic stress disorder (PTSD) is a chronic and often treatment-resistant psychiatric condition that emerges following exposure to trauma and is characterized by intrusive thoughts, emotional dysregulation, and cognitive impairments. In Israel, the prevalence of PTSD has increased significantly in the aftermath of the October 7, 2023 terror attacks, emphasizing the urgent need for more effective, accessible, and personalized interventions.
Existing treatments, such as trauma-focused CBT and SSRIs, remain only partially effective, with side effects that reduce adherence and limit long-term recovery. The proposed randomized controlled trial will assess and compare two promising treatment modalities: (i) a new pharmacological combination of reboxetine and methylphenidate, designed to enhance noradrenergic and dopaminergic pathways involved in attention and emotional regulation, and (ii) dog-assisted therapy (DAT), a non-pharmacological, group-based intervention shown to reduce PTSD symptoms and improve functioning. One hundred sixty adults with PTSD will be randomized into four groups: pharmacological treatment, placebo, DAT, or occupational therapy. The study will use validated clinical scales (CAPS-5, GAD-7, CAARS, DLQ, WHOQOLBREF) alongside neurophysiological tools (EEG, EDA, ASAT-based EMG). Data will feed into a machine-learning model to identify predictors of treatment response and support the development of personalized, neurobiologically informed approaches.
Detailed description
Posttraumatic Stress Disorder (PTSD) is a chronic and debilitating psychiatric condition characterized by intrusive memories, avoidance behaviors, hyperarousal, and emotional numbing. It is estimated that it affects 5.3% of the Israeli general population, though following the October 7, 2023 terror attacks, probable PTSD nearly doubled, from 16.2% to 29.8%, highlighting the urgent national need for effective and scalable PTSD interventions.
Given its high prevalence and physical and mental consequences, adequate treatment is needed. Current first-line therapies (TF-CBT and EMDR) are effective but are time-intensive, require specialized clinicians, and are not suitable for all patients. Pharmacological interventions, particularly SSRIs yield partial response rates (~60%) and often cause adherence-limiting side effects (e.g., major changes in body weight or loss of sexual drive). These limitations underscore the need for novel, tolerable, and mechanistically targeted therapies.
Arising evidence suggests a correlation between sensory dysfunction, impaired attention, and PTSD symptoms. The importance of combined treatment specifically targeting these difficulties has been suggested by us. Recent evidence suggests that PTSD involves dysregulation in both noradrenergic and dopaminergic systems, which play critical roles in attention, arousal, and emotional processing. Reboxetine, a norepinephrine reuptake inhibitor (NRI), and methylphenidate, a dopamine-enhancing psychostimulant, are hypothesized to have synergistic effects on PTSD-related cognitive and emotional deficits. Our lab's prior results suggest that this combination is safe, well-tolerated, and effective in reducing both clinician-rated PTSD symptoms, and neurophysiological dysregulations related to sensory gating and attention regulation, sensory processing, participation and quality of life.
Animal-assisted therapies, and DAT in particular, are increasingly recognized for their potential to reduce PTSD symptoms and improve emotional regulation. DAT programs for US veterans diagnosed with PTSD were found to be a helpful complementary or alternative treatment option for the veterans, demonstrating signs of meaningful improvements in mental and social health, lower PTSD symptoms severity and higher psychosocial functioning in veterans owning a psychiatric service dog, and positive correlation between Animal-assisted interventions (AAI) and a reduction of posttraumatic symptomatology. DAT programs have also been shown to foster resilience among veterans and their families. A meta-review found that DAT was as effective as traditional psychotherapy in symptom reduction. Our lab conducted a controlled study involving adolescents exposed to interpersonal trauma, showing significant improvement in PTSD symptoms, depression, and attentional regulation after a year-long dog training program (also on the dogs' attention and anxiety-like behavior).
Despite growing support for DAT and emerging evidence comparing DAT to psychotherapeutic interventions for PTSD symptomatology, no studies to date have directly compared pharmacological vs. animal-assisted therapy in PTSD. Moreover, there is a lack of objective, physiology-based tools to monitor treatment efficacy and guide individualized care. This study aims to bridge both gaps, combining a novel pharmacological strategy with neurophysiological diagnostics in a rigorously controlled, head-to-head RCT. Therefore, a four-arm randomized controlled trial (RCT) involving 160 adults diagnosed with PTSD, allocated to one of the following groups: 1. Combined pharmacological treatment (reboxetine + methylphenidate) 2. Pharmacological placebo control 3. Dog-assisted therapy (DAT) 4. Active control: Occupational therapy (OT) The pharmacological arm is double-blinded and placebo-controlled, while the DAT/OT arms are open-label, with participant preference and suitability guiding allocation. The study includes repeated measurements at multiple time points, combining subjective and objective outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Patients will be randomized into one of four groups: 1. Combined pharmacological treatment (reboxetine + methylphenidate) 2. Pharmacological placebo control 3. Dog-assisted therapy 4. Active control: Occupational therapy
| Arm | Type | Receives |
|---|---|---|
| Treatment with Reboxetine and Methylphenidate | Experimental | Drug: methylphenidate (Ritalin®), Drug: ReboxetineThe trial starts with four days of treatment with 2mg of reboxetine every morning at 8 am. For the rest of the first three weeks, the participants will increase their dosage to 4mg every morning. During the fourth week, the participants will continue taking 4mg of reboxetine every morning at 8 am and additionally take 10mg of methylphenidate (or matching placebo) twice daily, i.e., in the morning at 8 am and at noon. |
| Placebo | Placebo comparator | Drug: PlaceboThe patients will take placebos according to the medication schedule of the treatment group. |
| Dog-Assisted Therapy | Experimental | Behavioral: Dog-Assisted Therapy. To encompass DAT protocol variability, it will be provided by certified rehabilitation farms in Israel and the US. The twenty-four DAT group therapy weekly sessions, over six months, will be conducted by licensed clinicians trained in occupational therapy, social work, psychology, and counseling, and are certified (diploma) to facilitate group therapy using therapy dogs. The clinicians have, on average, over four years of experience in providing services to people diagnosed with PTSD. Groups will typically have eight to fifteen human participants, depending on the rehabilitation farm. The DAT session's duration will last between fifty to sixty minutes. In generalization, session protocol will include: (i) defining a subject for each of the twenty-four AATx sessions, from which the clinicians will extract the therapeutic messages they would like to convey (e.g. regaining a sense of control, dealing with feelings of anger, guilt or shame, reducing feelings of alienation and distance); |
| Occupational Therapy | Active comparator | Behavioral: Occupational TherapyThe occupational therapy schedule will roughly follow the same timeline as the dog-assisted therapy group. Therapy will be provided by licensed occupational therapists. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 18 and 70 years,
- diagnosed with PTSD according to DSM-IV or DSM-5 criteria,
- any psychotropic drug therapy that is being administered must be at a fixed dose for at least one month prior to the study initiation.
Key exclusion criteria (6 listed)
- any health condition for which the use of reboxetine or methylphenidate is contraindicated,
- comorbidity with major psychiatric disorder,
- significant/active cardiovascular disease,
- previous or current severe traumatic brain injury,
- active substance dependency,
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 |
|---|---|---|
| methylphenidate (Ritalin®)Also: RitalinRitalin 10mg | Drug | Treatment with Reboxetine and Methylphenidate |
| ReboxetineReboxetine 4mg | Drug | Treatment with Reboxetine and Methylphenidate |
| PlaceboPlacebo matched to Reboxetine | Drug | Placebo |
| PlaceboPlacebo matched to Ritalin | Drug | Placebo |
| Dog-Assisted TherapyDog-Assisted Therapy | Behavioural | Dog-Assisted Therapy |
| Occupational TherapyOccupational Therapy | Behavioural | Occupational Therapy |
Primary outcome
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
PTSD symptom severity score. Total of 56 questions. Minimum score 0, maximum score 80. A higher score reflects a worse outcome.
7 secondary outcomes
General Anxiety Disorder-7 (GAD-7)
Time frame: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
Conners' Adult ADHD Rating Scales (CAARS)
Time frame: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
Daily Life Questionnaire (DLQ)
Time frame: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Time frame: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
Electroencephalography (EEG)
Time frame: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
Electrodermal Activity (EDA)
Time frame: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
Electromyography (EMG) - Auditory Sustained Attention Test (ASAT-based)
Time frame: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.
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 18 Aug 2026.
- Background: PubMed 36807926Punski-Hoogervorst JL, Engel-Yeger B, Avital A. Attention deficits as a key player in the symptomatology of posttraumatic stress disorder: A review. J Neurosci Res. 2023 Jul;101(7):1068-1085. doi: 10.1002/jnr.25177. Epub 2023 Feb 20.
- Background: PubMed 34868486Maoz I, Zubedat S, Dolev T, Aga-Mizrachi S, Bloch B, Michaeli Y, Eshed Y, Grinstein D, Avital A. Dog training alleviates PTSD symptomatology by emotional and attentional regulation. Eur J Psychotraumatol. 2021 Nov 19;12(1):1995264. doi: 10.1080/20008198.2021.1995264. eCollection 2021.
- 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.
- 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.
- 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.
Janne L Punski-Hoogervorst, MD, PhD contact
Avi Avital, PhD principal investigator
University of Haifa
1 site 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 (Ritalin®), Reboxetine and Dog-Assisted Therapy in people with PTSD and Posttraumatic Stress Disorder, run by University of Haifa at 1 site 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 3 inclusion and 6 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 18 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 1 site 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?
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial.). 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 NCT07771530, which also lists 4 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 18 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.