Svojanov

Researchers are evaluating the efficacy, safety, and tolerability of CYB003, a deuterated psilocin analog, as an additional treatment for adults with Major Depressive Disorder (MDD). This Phase III, multi-center, double-blind, randomized controlled study compares two active doses of CYB003 against a placebo in patients experiencing moderate to severe depression who have not adequately responded to stable antidepressant treatment. Participants will receive either one of two doses of CYB003 or a placebo, along with manualized psychological support provided by a facilitator. The study includes a screening period, a dosing period, and follow-up assessments. The psychological support sessions are standardized to assist participants during the trial. During the study, participants will be assessed using the Montgomery-Asberg Depression Scale (MADRS) at multiple time points including screening, baseline, and several days during treatment up to the trial's end at Day 84. Researchers will monitor symptoms of depression, safety, and tolerability throughout the trial. Participants will also undergo various evaluations to ensure adherence and safety during the study period, which spans approximately 12 weeks from screening through the final assessment.