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NCT07300969PHASE2Recruiting

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

Draig Therapeutics Ltd

Start Date

12/16/2025

Completion Date

8/1/2027

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.

Detailed Description

The purpose of this study is to compare DT-101 and placebo in adult participants with MDD. The study will also evaluate how safe and well tolerated the study drug is. The clinical study staff will check participants' suitability to take part in the clinical research study by performing physical and neurological examinations, obtaining blood and urine samples, conducting clinical assessments and reviewing medical and treatment history. These tests and assessments will continue throughout the study with the purpose of checking the participants' ongoing suitability and to collect data to analyze the effect that DT-101 may have on their depression symptoms. Participants will also have blood samples taken to allow analysis of how DT-101 is absorbed and used by the body (PK sampling), some blood samples may be retained in order to perform future research that may be useful when looking at whether genetics affects how a person responds to DT-101 (PGx sampling)

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

DT-101

DRUG

DT-101

DRUG

Placebo

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Conditions

Major Depressive Disorder (MDD)

Locations

Draig Clinical Site

Bentonville, Arkansas 72712

United States

Draig Clinical Site

Little Rock, Arkansas 72211

United States

Draig Clinical Site

Oceanside, California 92056

United States

Draig Clinical Site

San Diego, California 92103

United States

Draig Clinical Site

Torrance, California 90502

United States

Draig Clinical Site

Miami, Florida 33166

United States

Draig Clinical Site

New Port Richey, Florida 34652

United States

Draig Clinical Site

Orlando, Florida 32803

United States

Draig Clinical Site

Atlanta, Georgia 30331

United States

Draig Clinical Site

Decatur, Georgia 30030

United States

Draig Clinical Site

Gaithersburg, Maryland 20877

United States

Draig Clinical Site

Watertown, Massachusetts 02472

United States

Draig Clinical Site

Flowood, Mississippi 39232

United States

Draig Clinical Site

Las Vegas, Nevada 89102

United States

Draig Clinical Site

Marlton, New Jersey 08009

United States

Draig Clinical Site

New York, New York 10312

United States

Draig Clinical Site

Media, Pennsylvania 19372

United States

Draig Clinical Site

Austin, Texas 78737

United States

Draig Clinical Site

Austin, Texas 78754

United States

Draig Clinical Site

DeSoto, Texas 75115

United States

Draig Clinical Site

Richardson, Texas 75243

United States

Draig Clinical Site

Wichita Falls, Texas 76309

United States

Draig Clinical Site

Bellevue, Washington 98004

United States

Draig Clinical Site

Kazanlak, 6100

Bulgaria

Draig Clinical Site

Pleven, 5980

Bulgaria

Draig Clinical Site

Plovdiv, 4000

Bulgaria

Draig Clinical Site

Sofia, 1606

Bulgaria

Draig Clinical Site

Vratsa, 3000

Bulgaria

Draig Clinical Site

Ostrava, 70868

Czechia

Draig Clinical Site

Prague, 10000

Czechia

Draig Clinical Site

Říčany, 25101

Czechia

Draig Clinical Site

Gdansk, 80-952

Poland

Draig Clinical Site

Katowice, 40-156

Poland

Draig Clinical Site

Poznan, 60-835

Poland

Draig Clinical Site

Chester, CH2 1HX

United Kingdom

Draig Clinical Site

Eastbourne, BN23 5UZ

United Kingdom

Draig Clinical Site

Glasgow, PA1 1JS

United Kingdom

Draig Clinical Site

London, SE5 8AF

United Kingdom

Draig Clinical Site

Nottingham, NG7 2TU

United Kingdom

Draig Clinical Site

Oxford, OX3 7JX

United Kingdom