Ricany U Prahy

Researchers are evaluating the effectiveness of DT-101 in treating adults with Major Depressive Disorder (MDD). This Phase 2 clinical trial compares DT-101 to a placebo to understand its impact on depression symptoms and evaluates the safety and tolerability of the study drug. Participants have recurrent depression diagnosed by the latest DSM manual and are between 18 and 75 years old. Participants will receive either DT-101 or placebo in a double-blind, randomized manner. The study includes physical and neurological examinations, blood and urine sample collections, and clinical assessments to monitor ongoing suitability and gather data on the drug's effects. Blood samples will also be used to study how DT-101 is absorbed and metabolized and to explore genetic factors that may influence treatment response. During the study, participants will visit the clinic every few weeks to undergo general health checks and complete questionnaires. Researchers will measure changes in depression using the Montgomery Åsberg Depression Rating Scale (MADRS) from the start of the study to Day 42. Safety and adherence will be closely monitored throughout the trial, ensuring participant well-being and data accuracy.