A Phase 2 Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults With Major Depressive Disorder (MDD)

What this Trial Is About

Researchers are evaluating the effects of DT-101 compared to a placebo in adults diagnosed with Major Depressive Disorder (MDD). This Phase 2 clinical trial aims to assess how well DT-101 works and how safe and tolerable it is for participants with recurrent depression, as defined by current psychiatric guidelines. The study is led by Draig Therapeutics Ltd and includes adult participants aged 18 to 75 years. Participants will be randomly assigned to receive one of two versions of DT-101 or a placebo. The study uses a double-blind design, meaning neither the participants nor the researchers know who receives which treatment until the trial ends. The treatment period includes regular visits every couple of weeks where health checks and questionnaires will be completed. Blood and urine samples will be collected for safety monitoring and to study how the drug is absorbed and processed by the body, including potential genetic influences. Throughout the study, participants will undergo physical and neurological examinations, clinical assessments, and ongoing health reviews to ensure continued eligibility and safety. Questionnaires will measure changes in depression symptoms using the Montgomery Åsberg Depression Rating Scale (MADRS) and the Clinician Global Impression of severity (CGI-S) by day 42. The total duration of participation will extend through these assessments, with safety and treatment effects closely monitored during clinic visits.

A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression