Recruiting
Phase 2

DT-101

Sponsor:

Draig Therapeutics Ltd

Code:

NCT07300969

Conditions

Major Depressive Disorder (MDD)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

DT-101

DT-101

Placebo

Study Details

Brief 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.

Conditions

Major Depressive Disorder (MDD)

Study ID

NCT07300969

Start date

Dec 16, 2025

Status verified date

Dec, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DT-101 A

experimental: DT-101 B

placebo comparator: Placebo

Interventions

DT-101

DT-101 A

DT-101

DT-101 B

Placebo

Placebo

Primary outcome measure

  • Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 42 [ Time Frame: from enrollment to day 42 ]

Central Contacts and Locations

Central contacts

Locations

Draig Clinical Site

Recruiting

Bentonville, Arkansas, United States, 72712

Contacts

Draig Clinical Site

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

Draig Clinical Site

Recruiting

Oceanside, California, United States, 92056

Contacts

Draig Clinical Site

Recruiting

San Diego, California, United States, 92103

Contacts

Draig Clinical Site

Recruiting

Torrance, California, United States, 90502

Contacts

Draig Clinical Site

Recruiting

Miami, Florida, United States, 33166

Contacts

Draig Clinical Site

Recruiting

New Port Richey, Florida, United States, 34652

Contacts

Draig Clinical Site

Recruiting

Orlando, Florida, United States, 32803

Contacts

Draig Clinical Site

Recruiting

Atlanta, Georgia, United States, 30331

Contacts

Draig Clinical Site

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Draig Clinical Site

Recruiting

Gaithersburg, Maryland, United States, 20877

Contacts

Draig Clinical Site

Recruiting

Watertown, Massachusetts, United States, 02472

Contacts

Draig Clinical Site

Recruiting

Flowood, Mississippi, United States, 39232

Contacts

Draig Clinical Site

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Draig Clinical Site

Recruiting

Marlton, New Jersey, United States, 08009

Contacts

Draig Clinical Site

Recruiting

New York, New York, United States, 10312

Contacts

Draig Clinical Site

Recruiting

Media, Pennsylvania, United States, 19372

Contacts

Draig Clinical Site

Recruiting

Austin, Texas, United States, 78737

Contacts

Draig Clinical Site

Recruiting

Austin, Texas, United States, 78754

Contacts

Draig Clinical Site

Recruiting

DeSoto, Texas, United States, 75115

Contacts

Draig Clinical Site

Recruiting

Richardson, Texas, United States, 75243

Contacts

Draig Clinical Site

Recruiting

Wichita Falls, Texas, United States, 76309

Contacts

Draig Clinical Site

Recruiting

Bellevue, Washington, United States, 98004

Contacts

More Information

Sponsor

Draig Therapeutics Ltd

Last update posted

Aug 26, 2026

Last verified

Dec, 2025

Keywords

  • MDD
  • Depression
  • DT-101
  • randomized
  • placebo controlled
  • major depressive disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Draig Therapeutics Ltd on 2026-08-26.