Major Depressive Disorder (MDD)Phase 2Tarian-1NCT07300969
A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression
A Phase 2 study testing DT-101 in people with Major Depressive Disorder (MDD), run by Draig Therapeutics Ltd at 43 sites in 5 countries.
Trial summary
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. Subjects will attend the clinic every couple of weeks complete general health checks and complete questionnaires. 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
- 300 participants
- Where
- 43 sitesin 5 countries
- Study dates
- 16 Dec 2025to Aug 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
43 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
43 sites in 5 countries
United States23 sites, 20 recruiting
- Recruiting
Draig Clinical Site
Atlanta, Georgia, 30331
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Austin, Texas, 78737
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Austin, Texas, 78754
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Bellevue, Washington, 98004
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Bentonville, Arkansas, 72712
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
Flowood, Mississippi, 39232
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Gaithersburg, Maryland, 20877
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Las Vegas, Nevada, 89102
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
Marlton, New Jersey, 08009
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Terminated
Draig Clinical Site
Media, Pennsylvania, 19372
- Recruiting
Draig Clinical Site
Miami, Florida, 33166
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Terminated
Draig Clinical Site
New Port Richey, Florida, 34652
- Recruiting
Draig Clinical Site
New York, New York, 10312
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Oceanside, California, 92056
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
Richardson, Texas, 75243
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
San Diego, California, 92103
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Torrance, California, 90502
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Watertown, Massachusetts, 02472
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Terminated
Draig Clinical Site
Wichita Falls, Texas, 76309
Bulgaria7 sites, 7 recruiting
- Recruiting
Draig Clinical Site
Kazanlak, 6100
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Plovdiv, 4000
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Sofia, 1113
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Sofia, 1202
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Sofia, 1510
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Sofia, 1606
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Vratsa, 3000
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
United Kingdom7 sites, 7 recruiting
- Recruiting
Draig Clinical Site
Chester, CH2 1HX
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Eastbourne, BN23 5UZ
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Glasgow, PA1 1JS
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
London, EC2Y 8EA
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
London, SE5 8AF
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Nottingham, NG7 2TU
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Oxford, OX3 7JX
Draig Clinical Site, +44(0)2920028450, info@draigtherapeutics.com
Czechia3 sites, 3 recruiting
- Recruiting
Draig Clinical Site
Ostrava, 70868
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Prague, 10000
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Říčany, 25101
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
Poland3 sites, 3 recruiting
- Recruiting
Draig Clinical Site
Gdansk, 80-952
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Katowice, 40-156
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
- Recruiting
Draig Clinical Site
Poznan, 60-835
Draig Clinical Site, +44 (0)2920028450, info@draigtherapeutics.com
About this study
Official title: A Phase 2 Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults With Major Depressive Disorder (MDD)
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. Subjects will attend the clinic every couple of weeks complete general health checks and complete questionnaires.
Read the detailed description
The purpose of this study is to compare DT-101 and placebo in adult participants with MDD. The study will also evaluate how safe and well tolerated the study drug is. The clinical study staff will check participants' suitability 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. These tests and assessments will continue throughout the study with the purpose of checking the participants' ongoing suitability and to collect data to analyze 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 (PK sampling), some blood samples may be retained in order to perform future research that may be useful when looking at whether genetics affects how a person responds to DT-101 (PGx sampling)
- 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 A
DT-101Drug
DT-101 B
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| DT-101 A | Experimental | Not described Receives: Drug: DT-101 |
| DT-101 B | 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 42
Measured: from enrollment to day 42
Secondary outcomes (1)
Change from baseline in Clinician Global Impression of severity (CGI-S), at Day 42
Measured: From enrollment until day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start16 Dec 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 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
- 300 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
- NCT07300969
- Sponsor's protocol ID
- DT-101/201
- Acronym
- Tarian-1
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 8 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 8 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 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults With Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT07300969
- Acronym / sponsor ID
- Tarian-1 / DT-101/201
- 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
- 300 participants (estimated)
- Lead sponsor
- Draig Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 24 Dec 2025 (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.
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. Subjects will attend the clinic every couple of weeks complete general health checks and complete questionnaires.
Detailed description
The purpose of this study is to compare DT-101 and placebo in adult participants with MDD. The study will also evaluate how safe and well tolerated the study drug is. The clinical study staff will check participants' suitability 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. These tests and assessments will continue throughout the study with the purpose of checking the participants' ongoing suitability and to collect data to analyze 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 (PK sampling), some blood samples may be retained in order to perform future research that may be useful when looking at whether genetics affects how a person responds to DT-101 (PGx sampling)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DT-101 A | Experimental | Drug: DT-101 |
| DT-101 B | 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 A | Drug | DT-101 A |
| DT-101DT-101 B | Drug | DT-101 B |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 42
Time frame: from enrollment to day 42
1 secondary outcome
Change from baseline in Clinician Global Impression of severity (CGI-S), at Day 42
Time frame: From enrollment until day 42
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 8 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.
43 sites in 5 countries: 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 43 sites in 5 countries.
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 8 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 43 sites in United States, Bulgaria, United Kingdom, Czechia, Poland. 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 Chief Medical Officer (+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 42 (time frame: from enrollment to day 42). 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 8 Oct 2026.