DT-101 as an extra treatment for adults with 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 Phase 2 randomized, placebo-controlled trial examines the safety and potential effectiveness of DT-101 as an adjunct therapy for adults with major depressive disorder who are already on antidepressant treatment. Participants will be randomly assigned to receive DT-101 or placebo for 8 weeks, with regular clinic visits, health checks, and questionnaires to monitor symptoms and tolerability. Blood and urine samples will be collected to study how the drug is absorbed and processed in the body. The study includes screening assessments to confirm eligibility and safety before starting treatment. Results will be analyzed to see if DT-101 provides additional relief from depressive symptoms beyond standard care.

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
  Phoenix, Arizona, United States Recruiting
• Draig Clinical Site
  Little Rock, Arkansas, United States Recruiting
• Draig Clinical Site
  Bellflower, California, United States Recruiting
• Draig Clinical Site
  Costa Mesa, California, United States Recruiting
• Draig Clinical Site
  Lafayette, California, United States Recruiting
• Draig Clinical Site
  Hialeah, Florida, United States Recruiting

Study contacts

• Study coordinator: Aeron-1 Clinical Team
• 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.