DT-101 for adults with recurrent major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Draig Clinical Site
  Bentonville, Arkansas, United States Recruiting
• Draig Clinical Site
  Little Rock, Arkansas, United States Recruiting
• Draig Clinical Site
  Oceanside, California, United States Recruiting
• Draig Clinical Site
  San Diego, California, United States Recruiting
• Draig Clinical Site
  Torrance, California, United States Recruiting
• Draig Clinical Site
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Chief Medical Officer
• Email: info@draigtherapeutics.com
• Phone: +44(0)2920028450

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.