Phase I Randomized Study of Skin Irritation and Sensitization of Investigational Compound XYZ in Adults with Major Depressive Disorder

The trial enrolled adult healthy volunteers of both sexes, including individuals classified as vulnerable, for evaluation of a therapy intended for major depressive disorder. The sponsor did not provide the total number of participants, and specific age limits were not disclosed; the protocol referenced an internal age‑range code (code 3) without further definition. Enrollment required participants to be free of the target psychiatric condition at baseline and to meet standard health criteria for healthy‑volunteer studies. No additional lifestyle restrictions or requirements were detailed.

The study is a Phase 3, Category 1, randomized, double‑blind, controlled trial evaluating a treatment for major depressive disorder. Recruitment is planned to begin 1 June 2026 with an estimated completion date of 1 December 2027, resulting in a total trial duration of approximately 18 months. Eligible participants will first attend a screening visit to confirm inclusion and exclusion criteria, followed by a baseline visit on Day 0 when the first dose is administered. Subsequent study visits are scheduled at weeks 2, 4, 8, 12, and then monthly until the end‑of‑study visit at Week 52, at which final efficacy and safety assessments are performed. Participant involvement therefore spans roughly one year from randomisation to the end‑of‑study assessment. Early termination may occur if a participant experiences a serious adverse event, withdraws consent, fails to comply with protocol‑required procedures, or if interim analysis indicates lack of efficacy or safety concerns.

Efficacy will be evaluated in accordance with the predefined study protocol for the Phase 3, Category 1 trial targeting major depressive disorder.