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

RecruitingPhase 2

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)

Who can join

Ages 18 to 75 · All sexes

Full eligibility criteria
Inclusion Criteria:

* The participant is able to read, understand and communicate in the local language used at the study site, and is willing to provide written informed consent
* Male or female (assigned at birth, inclusive of all gender identities) participant must be 18 to 75 years of age, inclusive at the time of signing the informed consent.
* Has recurrent depression (defined as at least one prior episode excluding the current one), as diagnosed by DSM 5-TR (Diagnostic and Statistical Manual of Mental Disorders, 2022).

Exclusion Criteria:

* Pregnant or breastfeeding or plans to become pregnant during the study.
* Unstable medical condition or unstable chronic disease.
* Significant neurological abnormality.
* History of moderate or severe alcohol or drug use disorder as per DSM-5-TR in the 6 months prior to Screening.
* History of seizure.
* In the investigator's opinion, the participant is not capable of adhering to the protocol requirements.

About the study

The goal of this clinical trial is to learn if DT-101 can treat depression in adults. The effect of DT-101 will be compared to placebo. Subjects will attend the clinic every couple of weeks complete general health checks and complete questionnaires.

What is being tested

Sponsor: Draig Therapeutics Ltd · Participants: 300 · Started: Dec 16, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07300969

Locations in the U.S.

ArkansasDraig Clinical Site, Bentonville
Draig Clinical Site, Little Rock
CaliforniaDraig Clinical Site, Oceanside
Draig Clinical Site, San Diego
Draig Clinical Site, Torrance
FloridaDraig Clinical Site, Miami
Draig Clinical Site, New Port Richey
Draig Clinical Site, Orlando
GeorgiaDraig Clinical Site, Atlanta
Draig Clinical Site, Decatur
MarylandDraig Clinical Site, Gaithersburg
MassachusettsDraig Clinical Site, Watertown
MississippiDraig Clinical Site, Flowood
NevadaDraig Clinical Site, Las Vegas
New JerseyDraig Clinical Site, Marlton
New YorkDraig Clinical Site, New York
PennsylvaniaDraig Clinical Site, Media
TexasDraig Clinical Site, Austin
Draig Clinical Site, Austin
Draig Clinical Site, DeSoto
Draig Clinical Site, Richardson
Draig Clinical Site, Wichita Falls
WashingtonDraig Clinical Site, Bellevue

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.