NCT07610473 · Draig Therapeutics Ltd
A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression
(AERON-1)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
DT-101
DT-101
DRUG
Placebo
Placebo
Primary outcome measures
Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56
Time frame: from enrolment to day 56
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Phoenix, Arizona
- Little Rock, Arkansas
- Bellflower, California
- Costa Mesa, California
- Lafayette, California
- Hialeah, Florida
- Orlando, Florida
- Tampa, Florida
- Decatur, Georgia
- Chicago, Illinois
- Skokie, Illinois
- Boston, Massachusetts
And 7 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 12, 2026 · Source of record for eligibility and locations