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

Last updated: April 30, 2026
Sponsor: Draig Therapeutics Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Depression

Treatment

Placebo

DT-101

Clinical Study ID

NCT07300969
DT-101/201
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • The participant is able to read, understand and communicate in the local languageused at the study site, and is willing to provide written informed consent

  • Male or female (assigned at birth, inclusive of all gender identities) participantmust be 18 to 75 years of age, inclusive at the time of signing the informedconsent.

  • Has recurrent depression (defined as at least one prior episode excluding thecurrent one), as diagnosed by DSM 5-TR (Diagnostic and Statistical Manual of MentalDisorders, 2022).

Exclusion

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 6months prior to Screening.

  • History of seizure.

  • In the investigator's opinion, the participant is not capable of adhering to theprotocol requirements.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 16, 2025
Estimated Completion Date:
August 31, 2027

Study 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)

Connect with a study center

  • Draig Clinical Site

    Kazanlak, 6100
    Bulgaria

    Site Not Available

  • Draig Clinical Site

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • Draig Clinical Site

    Sofia, 1606
    Bulgaria

    Active - Recruiting

  • Draig Clinical Site

    Vratsa, 3000
    Bulgaria

    Site Not Available

  • Draig Clinical Site

    Ostrava, 70868
    Czechia

    Site Not Available

  • Draig Clinical Site

    Prague, 10000
    Czechia

    Active - Recruiting

  • Draig Clinical Site

    Říčany, 25101
    Czechia

    Active - Recruiting

  • Draig Clinical Site

    Gdansk, 80-952
    Poland

    Site Not Available

  • Draig Clinical Site

    Katowice, 40-156
    Poland

    Site Not Available

  • Draig Clinical Site

    Poznan, 60-835
    Poland

    Site Not Available

  • Draig Clinical Site

    Chester, CH2 1HX
    United Kingdom

    Site Not Available

  • Draig Clinical Site

    Edinburgh, EH16 4SB
    United Kingdom

    Site Not Available

  • Draig Clinical Site

    Glasgow, PA1 1JS
    United Kingdom

    Site Not Available

  • Draig Clinical Site

    Glasgow 2648579, PA1 1JS
    United Kingdom

    Site Not Available

  • Draig Clinical Site

    London, SE5 8AF
    United Kingdom

    Site Not Available

  • Draig Clinical Site

    Nottingham, NG7 2TU
    United Kingdom

    Site Not Available

  • Draig Clinical Site

    Oxford, OX3 7JX
    United Kingdom

    Active - Recruiting

  • Draig Clinical Site

    Oxford 2640729, OX3 7JX
    United Kingdom

    Site Not Available

  • Draig Clinical Site

    Sheffield, S10 3TH
    United Kingdom

    Site Not Available

  • Draig Clinical Site

    Bentonville, Arkansas 72712
    United States

    Active - Recruiting

  • Draig Clinical Site

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

  • Draig Clinical Site

    Bentonville 4101260, Arkansas 4099753 72712
    United States

    Site Not Available

  • Draig Clinical Site

    Little Rock 4119403, Arkansas 4099753 72211
    United States

    Site Not Available

  • Draig Clinical Site

    Oceanside, California 92056
    United States

    Active - Recruiting

  • Draig Clinical Site

    San Diego, California 92103
    United States

    Active - Recruiting

  • Draig Clinical Site

    Torrance, California 90502
    United States

    Active - Recruiting

  • Draig Clinical Site

    Oceanside 5378771, California 5332921 92056
    United States

    Site Not Available

  • Draig Clinical Site

    San Diego 5391811, California 5332921 92103
    United States

    Site Not Available

  • Draig Clinical Site

    Torrance 5403022, California 5332921 90502
    United States

    Site Not Available

  • Draig Clinical Site

    Miami, Florida 33166
    United States

    Active - Recruiting

  • Draig Clinical Site

    New Port Richey, Florida 34652
    United States

    Active - Recruiting

  • Draig Clinical Site

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Draig Clinical Site

    Miami 4164138, Florida 4155751 33166
    United States

    Site Not Available

  • Draig Clinical Site

    New Port Richey 4165869, Florida 4155751 34652
    United States

    Site Not Available

  • Draig Clinical Site

    Orlando 4167147, Florida 4155751 32803
    United States

    Site Not Available

  • Draig Clinical Site

    Atlanta, Georgia 30331
    United States

    Active - Recruiting

  • Draig Clinical Site

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Draig Clinical Site

    Atlanta 4180439, Georgia 4197000 30331
    United States

    Site Not Available

  • Draig Clinical Site

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • Draig Clinical Site

    Gaithersburg, Maryland 20877
    United States

    Active - Recruiting

  • Draig Clinical Site

    Gaithersburg 4355843, Maryland 4361885 20877
    United States

    Site Not Available

  • Draig Clinical Site

    Watertown, Massachusetts 02472
    United States

    Active - Recruiting

  • Draig Clinical Site

    Watertown 4954611, Massachusetts 6254926 02472
    United States

    Site Not Available

  • Draig Clinical Site

    Flowood, Mississippi 39232
    United States

    Active - Recruiting

  • Draig Clinical Site

    Flowood 4426822, Mississippi 4436296 39232
    United States

    Site Not Available

  • Draig Clinical Site

    Las Vegas, Nevada 89102
    United States

    Active - Recruiting

  • Draig Clinical Site

    Las Vegas 5506956, Nevada 5509151 89102
    United States

    Site Not Available

  • Draig Clinical Site

    Marlton, New Jersey 08009
    United States

    Active - Recruiting

  • Draig Clinical Site

    Marlton 4502911, New Jersey 5101760 08009
    United States

    Site Not Available

  • Draig Clinical Site

    New York, New York 10312
    United States

    Active - Recruiting

  • Draig Clinical Site

    New York 5128581, New York 5128638 10312
    United States

    Site Not Available

  • Draig Clinical Site

    Media, Pennsylvania 19372
    United States

    Active - Recruiting

  • Draig Clinical Site

    Media 4559575, Pennsylvania 6254927 19372
    United States

    Site Not Available

  • Draig Clinical Site

    Austin, Texas 78754
    United States

    Active - Recruiting

  • Draig Clinical Site

    DeSoto, Texas 75115
    United States

    Active - Recruiting

  • Draig Clinical Site

    Richardson, Texas 75243
    United States

    Active - Recruiting

  • Draig Clinical Site

    Wichita Falls, Texas 76309
    United States

    Active - Recruiting

  • Draig Clinical Site

    Austin 4671654, Texas 4736286 78737
    United States

    Site Not Available

  • Draig Clinical Site

    DeSoto 4685524, Texas 4736286 75115
    United States

    Site Not Available

  • Draig Clinical Site

    Richardson 4722625, Texas 4736286 75243
    United States

    Site Not Available

  • Draig Clinical Site

    Wichita Falls 4741752, Texas 4736286 76309
    United States

    Site Not Available

  • Draig Clinical Site

    Bellevue, Washington 98004
    United States

    Active - Recruiting

  • Draig Clinical Site

    Bellevue 5786882, Washington 5815135 98004
    United States

    Site Not Available

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