Collado Villalba

Researchers are evaluating the safety and effectiveness of subcutaneous immunotherapy in patients aged 12 to 65 who have rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, and who are sensitive to cupressaceae and grass pollen. This phase 3, multicenter, randomized, double-blinded, placebo-controlled trial aims to better understand treatment options for allergy symptoms related to these pollens. Participants will be randomly assigned to one of three groups two groups receiving different doses of a purified and polymerized allergen extract from grasses and cupressaceae mixed with aluminum hydroxide, and one placebo group receiving a similar solution without active ingredients. The treatment will be given by subcutaneous injections and will last for 18 months. The study will monitor symptoms and medication use during the specific pollen seasons for cupressaceae January to March and grasses May to June. Throughout the trial, participants will record their symptoms and medication intake using an electronic diary via a smartphone. Researchers will assess combined symptom and medication scores as the primary outcome, along with various secondary measures such as symptom-free days, medication-free days, asthma and rhinitis symptom scores, quality of life, immunological parameters, and safety. The total participation time for each subject is 18 months, during which their health and response to treatment will be closely monitored.

Researchers are evaluating the effect of seltorexant as an add-on treatment to antidepressants in adults and elderly people with major depressive disorder who also have insomnia symptoms and have not responded well to their current antidepressant therapy with SSRIs or SNRIs. This Phase 3 study aims to understand how well seltorexant works, its safety, and its ability to maintain improvement compared with a placebo. Participants in part 1 of the study will receive either seltorexant or a matching placebo once daily for 6 weeks, alongside their usual SSRI or SNRI antidepressant. Those who complete part 1 and meet criteria for part 2, plus new participants entering directly into part 2, will receive seltorexant during an open-label induction and stabilization phase. Participants who respond well will then enter a double-blind maintenance phase, receiving either seltorexant or placebo daily, continuing their baseline antidepressant throughout. During the study, participants will be monitored through rating scales measuring depression severity, sleep disturbance, and patient health questionnaires at baseline and specified days up to two years and ten months. Researchers will assess changes in depression symptoms and time to relapse, along with safety and tolerability. Participants will be followed through treatment phases and post-treatment periods to evaluate the maintenance of effects and overall safety.