Major Depressive Disorder (MDD)Phase 2AERON-1NCT07610473
A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression
A Phase 2 study testing DT-101 in people with Major Depressive Disorder (MDD), run by Draig Therapeutics Ltd at 23 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- DT-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 23 sitesUnited States
- Study dates
- 14 May 2026to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United States23 sites, 23 recruiting
- Recruiting
Draig Clinical Site
Allentown, Pennsylvania, 18103
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Bellevue, Washington, 98007
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Bellflower, California, 90706
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Boston, Massachusetts, 02130
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Chicago, Illinois, 60610
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Columbus, Ohio, 43215
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Costa Mesa, California, 92626
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Decatur, Georgia, 30030
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
DeSoto, Texas, 75115
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Fort Worth, Texas, 76104
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Hialeah, Florida, 33016
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Lafayette, California, 94549
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Little Rock, Arkansas, 72211
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Media, Pennsylvania, 19063
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
New York, New York, 10025
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
New York, New York, 10029
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Orlando, Florida, 32803
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Orlando, Florida, 32807
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Phoenix, Arizona, 85013
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Seattle, Washington, 98104
Draig Clinical Site, +44(0)2920028450, draig.aeron@seattlentc.com
- Recruiting
Draig Clinical Site
Skokie, Illinois, 60076
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Tampa, Florida, 33607
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Tampa, Florida, 33613
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
About this study
Official 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
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.
Read the 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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- DT-101, Placebo
- Keywords
- MDD, Depression, DT-101, Randomized, Placebo Controlled, Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT-101Drug
DT-101
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| DT-101 | Experimental | Not described Receives: Drug: DT-101 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56
Measured: from enrolment to day 56
Secondary outcomes (1)
Change from baseline in Clinician Global Impression of severity (CGI-S), at Day 56
Measured: from enrolment to day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start14 May 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Draig Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610473
- Sponsor's protocol ID
- DT-101/202
- Acronym
- AERON-1
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07610473
- Acronym / sponsor ID
- AERON-1 / DT-101/202
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- MDD, Depression, DT-101, Randomized, Placebo Controlled, Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Draig Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- 14 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DT-101 | Experimental | Drug: DT-101 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DT-101DT-101 | Drug | DT-101 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56
Time frame: from enrolment to day 56
1 secondary outcome
Change from baseline in Clinician Global Impression of severity (CGI-S), at Day 56
Time frame: from enrolment to day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DT-101 in people with Major Depressive Disorder (MDD), run by Draig Therapeutics Ltd at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aeron-1 Clinical Team (+44(0)2920028450, info@draigtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56 (time frame: from enrolment to day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.