[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652167":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":56,"centralContacts":60,"locations":68,"responsibleParty":84,"collaborators":44,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":44,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":44,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":70,"whyStopped":44,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"University of Haifa","OTHER",[8,15,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14],"Drug: methylphenidate (Ritalin®)","Drug: Reboxetine",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo","PLACEBO_COMPARATOR","The patients will take placebos according to the medication schedule of the treatment group.",[20],"Drug: Placebo",{"label":22,"type":10,"description":23,"interventionNames":24},"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);",[25],"Behavioral: Dog-Assisted Therapy",{"label":27,"type":28,"description":29,"interventionNames":30},"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.",[31],"Behavioral: Occupational Therapy",[33,40,45,48,51,54],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","methylphenidate (Ritalin®)","Ritalin 10mg",[9],[39],"Ritalin",{"type":34,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Reboxetine","Reboxetine 4mg",[9],null,{"type":34,"name":16,"description":46,"armGroupLabels":47,"otherNames":44},"Placebo matched to Reboxetine",[16],{"type":34,"name":16,"description":49,"armGroupLabels":50,"otherNames":44},"Placebo matched to Ritalin",[16],{"type":52,"name":22,"description":22,"armGroupLabels":53,"otherNames":44},"BEHAVIORAL",[22],{"type":52,"name":27,"description":27,"armGroupLabels":55,"otherNames":44},[27],[57],{"name":58,"affiliation":5,"role":59},"Avi Avital, PhD","PRINCIPAL_INVESTIGATOR",[61,65],{"name":58,"role":62,"phone":63,"phoneExt":44,"email":64},"CONTACT","+972-4-8420-364","avitalavi@hotmail.com",{"name":66,"role":62,"phone":44,"phoneExt":44,"email":67},"Janne L Punski-Hoogervorst, MD, PhD","jhoogerv@campus.haifa.ac.il",[69],{"facility":5,"status":70,"city":71,"state":44,"zip":44,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"RECRUITING","Haifa","Israel","IL",{"type":75,"coordinates":76},"Point",[77,78],34.99928,32.81303,{"lat":78,"lon":77},[81,82],{"name":58,"role":62,"phone":63,"phoneExt":44,"email":64},{"name":83,"role":62,"phone":44,"phoneExt":44,"email":67},"Janne Punski-Hoogervorst, MD, PhD",{"type":59,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Avi Avital","Professor, Head of the Behavioural Neurobiology Lab","100652167","phase-2-the-efficacy-of-a-pharmacological-treatment-reboxetine-plus-ritalin-versus-dog-assisted-therapy-in-ptsd-100652167",false,"NCT07771530","The Efficacy of a Pharmacological Treatment (Reboxetine Plus Ritalin) Versus Dog-Assisted Therapy in PTSD","Evaluating the Efficacies of an Innovative Pharmacological Treatment (Reboxetine Plus Ritalin) Versus Dog-Assisted Therapy in PTSD: A Randomized Controlled Trial","Inclusion Criteria:\n\n* age between 18 and 70 years,\n* diagnosed with PTSD according to DSM-IV or DSM-5 criteria,\n* any psychotropic drug therapy that is being administered must be at a fixed dose for at least one month prior to the study initiation.\n\nExclusion Criteria:\n\n* any health condition for which the use of reboxetine or methylphenidate is contraindicated,\n* comorbidity with major psychiatric disorder,\n* significant\u002Factive cardiovascular disease,\n* previous or current severe traumatic brain injury,\n* active substance dependency,\n* participating in another treatment program for PTSD of any kind.","ALL","18 Years","70 Years",{"count":98,"type":99},160,"ESTIMATED","INTERVENTIONAL",[102],"PHASE2","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.\n\nExisting 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.",[105,106],"PTSD","Posttraumatic Stress Disorder",[105,106,41,108,109,110,27],"Methylphenidate","Randomized Controlled Trial","Dog-assisted Therapy","2026-08-14",{"date":113,"type":114},"2026-08-18","ACTUAL",{"date":116,"type":114},"2026-08-01",{"date":118,"type":99},"2028-08-01",{"name":5,"class":6},1]