DT-101 in Adults with Major Depressive Disorder
Research type
Research Study
Full title
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
IRAS ID
1013004
Contact name
Helen Watson
Contact email
Sponsor organisation
Draig Therapeutics Ltd
Research summary
A clinical research study looking at a new medication in the treatment of Major Depressive Disorder (MDD), also known as clinical depression. MDD is one of the most common mental health conditions & one of the leading causes of global disease burden. It is characterised by persistent feelings of sadness, hopelessness & loss of interest or pleasure in activities that were once enjoyed.
The Sponsor has developed a study medicine called DT-101 for the treatment of MDD & will conduct a clinical research study to evaluate how well DT-101 works in reducing depressive symptoms in people with MDD & how safe it is to use in adult people.
Participants will be between 18 to 65 years old when they join this study.
DT-101 is a small molecule that helps specific brain receptors (called AMPA receptors) work better by making them more responsive to the brain’s natural messenger. That way brain cells can communicate more effectively.
The purpose of this study is to compare DT-101 & placebo in adults with MDD
The study is a randomised, “double-blind” study, which means participants & study staff do not know which treatment the participant receives. The placebo treatment looks identical to the DT-101 capsule without any medicine in it. Treatment is taken once daily by mouth with water & without food.
The study is split into a screening period, a treatment period & a follow up visit . Participants attend the site for study visits every 1-2 weeks . At the end of the study participants will return to receiving standard care from their usual primary care doctor.
REC name
London - Chelsea Research Ethics Committee
REC reference
25/LO/0824
Date of REC Opinion
16 Dec 2025
REC opinion
Further Information Favourable Opinion