Recruiting
Phase 2

DT-101

Sponsor:

Draig Therapeutics Ltd

Code:

NCT07610473

Conditions

Major Depressive Disorder (MDD)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

DT-101

Placebo

Study Details

Brief summary:

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.

Conditions

Major Depressive Disorder (MDD)

Study ID

NCT07610473

Start date

May 14, 2026

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 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

118 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DT-101

placebo comparator: Placebo

Interventions

DT-101

DT-101

Placebo

Placebo

Primary outcome measure

  • Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56 [ Time Frame: from enrolment to day 56 ]

Central Contacts and Locations

Central contacts

Locations

Draig Clinical Site

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Draig Clinical Site

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

Draig Clinical Site

Recruiting

Bellflower, California, United States, 90706

Contacts

Draig Clinical Site

Recruiting

Costa Mesa, California, United States, 92626

Contacts

Draig Clinical Site

Recruiting

Lafayette, California, United States, 94549

Contacts

Draig Clinical Site

Recruiting

Hialeah, Florida, United States, 33016

Contacts

Draig Clinical Site

Recruiting

Orlando, Florida, United States, 32803

Contacts

Draig Clinical Site

Recruiting

Orlando, Florida, United States, 32807

Contacts

Draig Clinical Site

Recruiting

Tampa, Florida, United States, 33607

Contacts

Draig Clinical Site

Recruiting

Tampa, Florida, United States, 33613

Contacts

Draig Clinical Site

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Draig Clinical Site

Recruiting

Chicago, Illinois, United States, 60610

Contacts

Draig Clinical Site

Recruiting

Skokie, Illinois, United States, 60076

Contacts

Draig Clinical Site

Recruiting

Boston, Massachusetts, United States, 02130

Contacts

Draig Clinical Site

Recruiting

New York, New York, United States, 10025

Contacts

Draig Clinical Site

Recruiting

New York, New York, United States, 10029

Contacts

Draig Clinical Site

Recruiting

Columbus, Ohio, United States, 43215

Contacts

Draig Clinical Site

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Draig Clinical Site

Recruiting

Media, Pennsylvania, United States, 19063

Contacts

Draig Clinical Site

Recruiting

DeSoto, Texas, United States, 75115

Contacts

Draig Clinical Site

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Draig Clinical Site

Recruiting

Bellevue, Washington, United States, 98007

Contacts

Draig Clinical Site

Recruiting

Seattle, Washington, United States, 98104

Contacts

More Information

Sponsor

Draig Therapeutics Ltd

Last update posted

Sep 2, 2026

Last verified

May, 2026

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 2026-09-02.