Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07610473

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Major Depressive Disorder (MDD) Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Draig Clinical Site, Phoenix, Arizona, United States

Loading trial locations.

About this study

The purpose of this study is to compare DT-101 and placebo in adult participants with MDD already receiving medication for depression. The clinical study will also evaluate how safe and well tolerated the study drug is. Potential participants will be assessed if they are suitable to take part in the clinical research study by performing physical and neurological examinations, obtaining blood and urine samples, conducting clinical assessments and reviewing medical and treatment history. After successfully passing screening into the study, participants will be randomly assigned to receive either DT-101 or placebo for the study. Over the next 8 weeks, these tests and assessments will continue throughout the study with the purpose of checking the participants' ongoing suitability and to collect data to analyse the effect that DT-101 may have on their depression symptoms. Participants will also have blood samples taken to allow analysis of how DT-101 is absorbed and used by the body.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DT-101

Drug

DT-101

Placebo

Drug

Placebo

Primary outcomes

  1. Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56

    Time frame: from enrolment to day 56

Secondary outcomes

  1. Change from baseline in Clinician Global Impression of severity (CGI-S), at Day 56

    Time frame: from enrolment to day 56

Study contacts

Contact information is provided by the study sponsor or research team.

Aeron-1 Clinical Team

CONTACT

[email protected]

+44(0)2920028450

Sponsors and collaborators

Lead sponsor

Draig Therapeutics Ltd

Industry

Registry information

Official study title

A Phase 2 Double-blind, Randomised, Placebo-controlled Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults With Major Depressive Disorder Receiving Pharmacological Therapy for Depression

Acronym: AERON-1

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 28, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.