A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder (MDD)

In brief

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.

Key facts

Study ID

NCT07610473

Run by

Draig Therapeutics Ltd

People needed

118

Starts

2026-06-01

Expected to finish

2027-05-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Draig Clinical Site — Phoenix, Arizona, United States (enrolling)
• Draig Clinical Site — Little Rock, Arkansas, United States (enrolling)
• Draig Clinical Site — Costa Mesa, California, United States (enrolling)
• Draig Clinical Site — Lafayette, California, United States (enrolling)
• Draig Clinical Site — Hialeah, Florida, United States (enrolling)
• Draig Clinical Site — Orlando, Florida, United States (enrolling)
• Draig Clinical Site — Orlando, Florida, United States (enrolling)
• Draig Clinical Site — Tampa, Florida, United States (enrolling)
• Draig Clinical Site — Tampa, Florida, United States (enrolling)
• Draig Clinical Site — Decatur, Georgia, United States (enrolling)
• Draig Clinical Site — Chicago, Illinois, United States (enrolling)
• Draig Clinical Site — Boston, Massachusetts, United States (enrolling)
• Draig Clinical Site — New York, New York, United States (enrolling)
• Draig Clinical Site — New York, New York, United States (enrolling)
• Draig Clinical Site — Columbus, Ohio, United States (enrolling)
• Draig Clinical Site — Media, Pennsylvania, United States (enrolling)
• Draig Clinical Site — DeSoto, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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