Collado Villalba

Researchers are evaluating the safety and effectiveness of subcutaneous immunotherapy in people aged 12 to 65 who have allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, sensitized to cupressaceae and grass pollens. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to compare active treatments with a placebo over an 18-month period. The study focuses on reducing symptoms and medication use during the pollen seasons of cupressaceae (January to March) and grasses (May to June). Participants will receive one of three treatments: two different doses of purified and polymerized allergen extracts from a mix of grasses and cupressaceae, or a placebo that looks the same but contains no active ingredients. These treatments are given as subcutaneous injections. Each participant will be treated and monitored for 18 months, covering multiple pollen seasons with continuous dosing. During the study, participants will track their symptoms and medication use daily using an electronic diary on their smartphone. Researchers will assess combined symptom and medication scores to measure treatment effects during pollen seasons. Safety and adherence will be monitored throughout the 18 months. The study involves 180 participants and includes various clinical assessments to ensure accurate evaluation of treatment impact and participant wellbeing.

Researchers are evaluating how well seltorexant works and its safety as an added treatment to antidepressants in adults and elderly participants who have major depressive disorder with insomnia symptoms (MDDIS). The study focuses on people who have not responded adequately to current antidepressant therapy with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This Phase 3 trial aims to assess the improvement of depressive symptoms and the maintenance effect of seltorexant compared to a placebo. Participants will receive either seltorexant or a matching placebo taken orally alongside their current antidepressant medication, which includes SSRIs or SNRIs. The study is divided into two parts: Part 1 evaluates changes in depression severity after 43 days, while Part 2 monitors the time to relapse for up to nearly three years in participants who achieved a stable response. Participants must continue their stable antidepressant dose during the study. During the study, participants will be assessed using the Montgomery-Asberg Depression Rating Scale to measure changes in depression symptoms and monitored for relapse over time. Safety and tolerability will also be evaluated throughout. The total participation includes an initial treatment phase and an extended maintenance phase, allowing researchers to understand both short-term and long-term effects of seltorexant as an adjunctive therapy.