A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of DT-101 in Adults with Major Depressive Disorder

The primary objective is to evaluate the efficacy of various dose levels of DT-101 compared to a placebo in reducing depressive symptoms in adults diagnosed with major depressive disorder.

This study involves 223 participants diagnosed with Major Depressive Disorder. The study population includes both male and female individuals, aged 18 to 65 years. Eligible participants must have a history of recurrent depression, as defined by at least one prior episode according to the Diagnostic and Statistical Manual of Mental Disorders. The current depressive episode must have persisted for a minimum of 6 weeks prior to the screening visit. The primary objective is to evaluate the effects of various dose levels of DT-101 and a placebo on depressive symptoms.

This Phase 2, double-blind, randomised, placebo-controlled study is designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of DT-101 in adults diagnosed with Major Depressive Disorder. The primary objective is to assess the effects of different dose levels of the investigational product compared to a placebo on depressive symptoms, specifically measuring the change in the Montgomery Åsberg Depression Rating Scale (MADRS) score. The study involves a screening process to identify participants aged 18 to 65 with recurrent depression as defined by the DSM-5-TR. The clinical trial methodology includes an initial assessment followed by periods of oral administration of either DT-101 or a matching placebo capsule. Detailed information regarding the specific sequence of follow-up visits, total duration of participant involvement, and criteria for early termination is not provided in the current data.

The experimental medication DT-101 is administered as an oral capsule. The administration route is per os.

A matching placebo capsule is utilized for oral administration to serve as a comparator during the study.

The efficacy of DT-101 in the treatment of major depressive disorder is evaluated by assessing changes in depressive symptoms. The primary endpoint is the change from baseline in the score obtained via the Montgomery Åsberg Depression Rating Scale (MADRS).