RecruitingPhase 2NCT07300969

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

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)

Sponsor

Draig Therapeutics Ltd

Enrollment

300 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder (MDD)

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating how well a treatment called DT-101 works for people with recurrent depression — meaning they have had at least one previous episode of depression and are currently experiencing another. Researchers want to understand its effectiveness in real-world clinical conditions. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with recurrent major depression (at least one prior episode, plus your current one) - Your diagnosis follows the DSM-5 criteria (the standard medical criteria for depression) - You are able to read and communicate in the local study language - You are willing to give written consent **You may NOT be eligible if...** - You have bipolar disorder, psychosis, or certain other psychiatric conditions - You are actively suicidal - You have already tried DT-101 or similar treatments - You are pregnant or breastfeeding - You have serious medical conditions that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDT-101

DT-101 A

DRUGDT-101

DT-101 B

DRUGPlacebo

Placebo

Locations(40)

Draig Clinical Site

Bentonville, Arkansas, United States

Draig Clinical Site

Little Rock, Arkansas, United States

Draig Clinical Site

Oceanside, California, United States

Draig Clinical Site

San Diego, California, United States

Draig Clinical Site

Torrance, California, United States

Draig Clinical Site

Miami, Florida, United States

Draig Clinical Site

New Port Richey, Florida, United States

Draig Clinical Site

Orlando, Florida, United States

Draig Clinical Site

Atlanta, Georgia, United States

Draig Clinical Site

Decatur, Georgia, United States

Draig Clinical Site

Gaithersburg, Maryland, United States

Draig Clinical Site

Watertown, Massachusetts, United States

Draig Clinical Site

Flowood, Mississippi, United States

Draig Clinical Site

Las Vegas, Nevada, United States

Draig Clinical Site

Marlton, New Jersey, United States

Draig Clinical Site

New York, New York, United States

Draig Clinical Site

Media, Pennsylvania, United States

Draig Clinical Site

Austin, Texas, United States

Draig Clinical Site

Austin, Texas, United States

Draig Clinical Site

DeSoto, Texas, United States

Draig Clinical Site

Richardson, Texas, United States

Draig Clinical Site

Wichita Falls, Texas, United States

Draig Clinical Site

Bellevue, Washington, United States

Draig Clinical Site

Kazanlak, Bulgaria

Draig Clinical Site

Plovdiv, Bulgaria

Draig Clinical Site

Sofia, Bulgaria

Draig Clinical Site

Vratsa, Bulgaria

Draig Clinical Site

Ostrava, Czechia

Draig Clinical Site

Prague, Czechia

Draig Clinical Site

Říčany, Czechia

Draig Clinical Site

Gdansk, Poland

Draig Clinical Site

Katowice, Poland

Draig Clinical Site

Poznan, Poland

Draig Clinical Site

Chester, United Kingdom

Draig Clinical Site

Edinburgh, United Kingdom

Draig Clinical Site

Glasgow, United Kingdom

Draig Clinical Site

London, United Kingdom

Draig Clinical Site

Nottingham, United Kingdom

Draig Clinical Site

Oxford, United Kingdom

Draig Clinical Site

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07300969

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