Hod Hasharon

Researchers are investigating new treatments for children with different types of advanced, relapsed, or refractory melanoma, solid tumors, and lymphomas that cannot be cured by surgery or have not responded well to previous therapies. This study focuses on evaluating pembrolizumab, an immunotherapy drug that helps the immune system fight cancer. The study is a Phase I/II trial that includes children from 6 months to under 18 years old, but some enrollment groups have closed based on recent amendments. Participants will receive pembrolizumab through an intravenous infusion. The study includes multiple groups based on cancer type, including melanoma, classical Hodgkin lymphoma, and solid tumors with specific genetic markers. The treatment aims to assess different doses of pembrolizumab to see if it can shrink or eliminate tumors. Enrollment for some groups, such as children under 12 with melanoma and certain tumor types, has been closed as the trial progresses. During the study, participants will be evaluated for tumor response using established criteria and monitored for side effects and toxicities for up to two years. Researchers will collect tissue samples and conduct regular assessments including scans, laboratory tests, and physical exams. The study tracks safety, treatment discontinuations due to adverse events, and overall response rates to understand the drug’s effects in these pediatric cancers.

Researchers are evaluating the long-term safety and tolerability of KarXT in treating mania or mania with mixed features in adults with Bipolar-I disorder. This phase 3, open-label extension study aims to better understand how KarXT performs over an extended period in this population. The study includes participants who either completed previous double-blind placebo-controlled studies or are newly diagnosed with Bipolar-I disorder experiencing manic symptoms. Participants receive KarXT at specified doses on certain days, with some also taking therapeutic doses of Lithium, Valproate, or Lamotrigine as part of their treatment. The study does not mention a placebo group during this extension, focusing instead on monitoring the long-term effects of KarXT alone or in combination with these established therapies. During the study, participants are monitored for adverse events up to week 54 to assess safety. Evaluations include psychiatric assessments using scales such as the Young Mania Rating Scale and CGI-BP score at screening and baseline. Researchers will track treatment-emergent adverse events and overall tolerability throughout the study duration, which lasts up to 54 weeks for each participant.

Researchers are evaluating the safety and effectiveness of adding KarXT (Xanomeline/Trospium Chloride) to standard treatment for mania in adults with Bipolar-I Disorder. This Phase 3, randomized, double-blind study focuses on individuals experiencing acute manic episodes, with or without mixed features, who are already taking lithium, valproate, or lamotrigine. The study aims to measure changes in mania symptoms using the Young Mania Rating Scale at Week 5. Participants will be randomly assigned to receive either KarXT or a placebo alongside their stable dose of lithium, valproate, or lamotrigine. The doses of these medications are specified and given on set days during the study. Only those with stable mood stabilizer doses for at least two weeks prior to screening, and valproate treatment for at least seven months, are eligible. The treatment period lasts for 5 weeks. During the study, participants will be closely monitored through psychiatric evaluations and clinical assessments. Researchers will assess mania severity, safety, and any side effects. The main outcome is the change from baseline in the Young Mania Rating Scale score at Week 5. Participants’ physical health, including liver function and risk of urinary or gastrointestinal issues, will also be monitored to ensure safety throughout the trial.

Researchers are evaluating the safety and effectiveness of KarXT compared to a placebo for treating adults with Bipolar-I disorder experiencing an acute episode of mania or mania with mixed features. This Phase 3 study involves participants who require hospitalization due to their manic episode and aims to assess symptom improvement over a short-term inpatient period. The study lasts up to seven weeks, including screening, treatment, and safety follow-up. Participants will be randomly assigned to receive either KarXT or a placebo in specified doses during a three-week inpatient treatment period. The study is conducted in a double-blind manner, meaning neither the participants nor the researchers know who receives the active drug or placebo. The focus is on the change in mania symptoms measured by the Young Mania Rating Scale during the three weeks. Throughout the study, participants will be closely monitored with psychiatric evaluations and rating scales, including the Young Mania Rating Scale and Clinical Global Impressions-Bipolar scale. Safety assessments continue during the follow-up period. The total participation time, from screening through treatment and safety monitoring, will not exceed seven weeks.

Researchers are investigating the psychological impact of the multi-regional war in Israel starting October 7th, 2023, focusing on children and adolescents who are sensitive to traumatic events. This study aims to understand the extent of distress and mental and physical health consequences among children and their parents, while also examining psychotherapy outcomes and dropout rates in this context. The study combines a retrospective big-data analysis and a prospective evaluation of ongoing psychotherapies to explore both pre-treatment and within-treatment factors influencing therapy outcomes. The study has two phases. Phase I is a retrospective analysis using Clalit Health Services databases to assess mental and physical health effects and psychotherapy dropout rates among children and adolescents aged 6-18 from 2015 to 2024. Phase II is a prospective study involving patients aged 11-18 receiving psychotherapy at Shalvata Mental Health Center's Crisis Intervention Unit, along with their caregivers and therapists. Participants undergo assessments at baseline, week 1, week 4, and week 7 to evaluate therapy progress and predictors of dropout and outcomes. Participants will provide information through questionnaires assessing symptoms, therapeutic alliance, treatment expectations, and exposure to traumatic events. Researchers will collect demographic, mental health, and general health data. Outcomes measured include dropout rates, symptom reduction over up to 7 weeks of treatment, and health services use tracked over four years surrounding psychotherapy. The study also involves safety monitoring and consent procedures for parents, including special steps for divorced parents. Total participation duration varies per phase with detailed assessments throughout therapy.

Researchers are investigating how oxytocin (OT), a natural hormone involved in social communication and bonding, affects the therapeutic process between patients with severe mental illness and their therapists. This Phase 2 pilot study explores whether administering OT to patients alone or to both patients and therapists influences physiological synchronization (PS) during therapy, which is the coordination of bodily signals between interacting individuals and is believed to be linked to better therapeutic outcomes and empathy. The study involves 60 patient-therapist pairs from inpatient psychiatric wards. Participants will be randomly assigned to receive intranasal oxytocin or a placebo in a double-blind setup. Patients receive OT or placebo before the first session, and both patients and therapists receive the assigned substance before the second session. Each session includes a 30-minute wait after administration, during which skin conductance synchrony is measured using a galvanic skin response device. Therapeutic process measurements, including perceived empathy and alliance, are collected after each session alongside side-effect questionnaires. Participants will complete self-report questionnaires on symptoms, attachment, therapeutic alliance, empathy, and session impact. Electrodermal activity recordings assess physiological synchronization during sessions. Safety monitoring includes checking for side effects reported in previous OT studies. The study lasts over two therapy sessions, focusing on understanding how OT affects the patient-therapist bond and therapeutic change mechanisms.

Researchers are investigating how immune-inflammatory markers and their interaction with the oxytocin system may influence the development of posttraumatic stress disorder (PTSD) and patients' responses to psychotherapy. This study focuses on patients experiencing trauma-related distress, aiming to better understand biological factors that could affect treatment outcomes given that many patients do not achieve full remission with current PTSD therapies. Participants will undergo 12 weeks of psychotherapy, with sessions held once per week. During the study, researchers will measure levels of oxytocin and inflammatory cytokines in saliva before and after therapy sessions 1, 6, and 12. Participants will also complete self-report questionnaires about their psychotherapy outcomes following these sessions. Throughout the study, participants will be monitored for changes in oxytocin secretion, inflammatory responses involving IL-1β, IL-6, and TNF-α, as well as PTSD symptoms, depression severity, and general anxiety symptoms. These evaluations will occur between weeks 12 and 16, depending on treatment duration, to assess biological and psychological changes associated with therapy.