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DT-101 for adults with recurrent major depressive disorder

A Phase 2 Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults With Major Depressive Disorder (MDD)

PHASE2 · Draig Therapeutics Ltd · NCT07300969

This trial will test whether DT-101 helps adults with recurrent major depressive disorder compared with a placebo.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorDraig Therapeutics Ltd (industry)
Locations40 sites (Bentonville, Arkansas and 39 other locations)
Trial IDNCT07300969 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled Phase 2 trial enrolls adults with recurrent major depressive disorder to compare DT-101 against placebo. Participants visit the clinic every few weeks for health checks, symptom questionnaires, and safety monitoring. Blood and urine samples will be collected for standard safety labs, pharmacokinetic (PK) testing, and optional pharmacogenetic (PGx) research. The study excludes people who are pregnant or breastfeeding, have unstable medical or neurological conditions, recent substance use disorders, or a history of seizures.

Who should consider this trial

Good fit: Adults aged 18 to 75 with recurrent major depressive disorder who can consent, attend regular clinic visits, and do not have exclusionary medical, neurological, pregnancy, seizure, or recent substance-use conditions are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have unstable medical or neurological conditions, a history of seizures, recent moderate-to-severe substance use disorder, or who cannot adhere to study visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, DT-101 could reduce depression symptoms and improve daily functioning for adults with recurrent MDD.

How similar studies have performed: DT-101 is an investigational agent and randomized, placebo-controlled Phase 2 trials of novel antidepressants have shown mixed results in the past, so this approach is common but not guaranteed to succeed.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Bentonville, Arkansas and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Major Depressive Disorder, MDD, Depression, DT-101, randomized, placebo controlled, major depressive disorder

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.