A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression (AERON-1)

September 1, 2026 updated by: Draig Therapeutics Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

118

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
    • California
      • Bellflower, California, United States, 90706
      • Costa Mesa, California, United States, 92626
      • Lafayette, California, United States, 94549
    • Florida
      • Hialeah, Florida, United States, 33016
      • Orlando, Florida, United States, 32803
      • Orlando, Florida, United States, 32807
      • Tampa, Florida, United States, 33607
      • Tampa, Florida, United States, 33613
    • Georgia
      • Decatur, Georgia, United States, 30030
    • Illinois
      • Chicago, Illinois, United States, 60610
      • Skokie, Illinois, United States, 60076
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
    • New York
      • New York, New York, United States, 10025
      • New York, New York, United States, 10029
    • Ohio
      • Columbus, Ohio, United States, 43215
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
      • Media, Pennsylvania, United States, 19063
    • Texas
      • DeSoto, Texas, United States, 75115
      • Fort Worth, Texas, United States, 76104
    • Washington
      • Bellevue, Washington, United States, 98007
      • Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: DT-101
Drug: DT-101
DT-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56
Time Frame: from enrolment to day 56
from enrolment to day 56

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Clinician Global Impression of severity (CGI-S), at Day 56
Time Frame: from enrolment to day 56
from enrolment to day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Draig Therapeutics Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DT-101/202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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