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A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression

In this study, researchers will learn more about a study drug called DT-101 in participants with Major Depressive Disorder (MDD), a form of depression. 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. A placebo looks the drug but contains no medicine. Subjects will attend the clinic for complete general health checks and to complete questionnaires.

ClinicalTrials.gov IDNCT07610473

PhasePHASE2

Enrollment118

SponsorDraig Therapeutics Ltd

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Major Depressive Disorder (MDD)

About this study

Interventions

Drug: DT-101 — DT-101
Drug: Placebo — Placebo

Primary outcomes

Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56 (from enrolment to day 56)

Eligibility information

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.

Study locations

Draig Clinical Site, Phoenix, Arizona 85013 United States
Draig Clinical Site, Little Rock, Arkansas 72211 United States
Draig Clinical Site, Bellflower, California 90706 United States
Draig Clinical Site, Costa Mesa, California 92626 United States
Draig Clinical Site, Lafayette, California 94549 United States
Draig Clinical Site, Hialeah, Florida 33016 United States
Draig Clinical Site, Orlando, Florida 32803 United States
Draig Clinical Site, Orlando, Florida 32807 United States
Draig Clinical Site, Tampa, Florida 33607 United States
Draig Clinical Site, Tampa, Florida 33613 United States

Showing 10 of 23 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.