A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression
Tarian-1
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)
1 other identifier
interventional
300
5 countries
40
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2025
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 16, 2025
CompletedFirst Submitted
Initial submission to the registry
December 22, 2025
CompletedFirst Posted
Study publicly available on registry
December 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
May 1, 2026
December 1, 2025
1.6 years
December 22, 2025
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 42
from enrollment to day 42
Secondary Outcomes (1)
Change from baseline in Clinician Global Impression of severity (CGI-S), at Day 42
From enrollment until day 42
Study Arms (3)
DT-101 A
EXPERIMENTALDT-101 B
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Draig Clinical Site
Bentonville, Arkansas, 72712, United States
Draig Clinical Site
Little Rock, Arkansas, 72211, United States
Draig Clinical Site
Oceanside, California, 92056, United States
Draig Clinical Site
San Diego, California, 92103, United States
Draig Clinical Site
Torrance, California, 90502, United States
Draig Clinical Site
Miami, Florida, 33166, United States
Draig Clinical Site
New Port Richey, Florida, 34652, United States
Draig Clinical Site
Orlando, Florida, 32803, United States
Draig Clinical Site
Atlanta, Georgia, 30331, United States
Draig Clinical Site
Decatur, Georgia, 30030, United States
Draig Clinical Site
Gaithersburg, Maryland, 20877, United States
Draig Clinical Site
Watertown, Massachusetts, 02472, United States
Draig Clinical Site
Flowood, Mississippi, 39232, United States
Draig Clinical Site
Las Vegas, Nevada, 89102, United States
Draig Clinical Site
Marlton, New Jersey, 08009, United States
Draig Clinical Site
New York, New York, 10312, United States
Draig Clinical Site
Media, Pennsylvania, 19372, United States
Draig Clinical Site
Austin, Texas, 78737, United States
Draig Clinical Site
Austin, Texas, 78754, United States
Draig Clinical Site
DeSoto, Texas, 75115, United States
Draig Clinical Site
Richardson, Texas, 75243, United States
Draig Clinical Site
Wichita Falls, Texas, 76309, United States
Draig Clinical Site
Bellevue, Washington, 98004, United States
Draig Clinical Site
Kazanlak, 6100, Bulgaria
Draig Clinical Site
Plovdiv, 4000, Bulgaria
Draig Clinical Site
Sofia, 1606, Bulgaria
Draig Clinical Site
Vratsa, 3000, Bulgaria
Draig Clinical Site
Ostrava, 70868, Czechia
Draig Clinical Site
Prague, 10000, Czechia
Draig Clinical Site
Říčany, 25101, Czechia
Draig Clinical Site
Gdansk, 80-952, Poland
Draig Clinical Site
Katowice, 40-156, Poland
Draig Clinical Site
Poznan, 60-835, Poland
Draig Clinical Site
Chester, CH2 1HX, United Kingdom
Draig Clinical Site
Edinburgh, EH16 4SB, United Kingdom
Draig Clinical Site
Glasgow, PA1 1JS, United Kingdom
Draig Clinical Site
London, SE5 8AF, United Kingdom
Draig Clinical Site
Nottingham, NG7 2TU, United Kingdom
Draig Clinical Site
Oxford, OX3 7JX, United Kingdom
Draig Clinical Site
Sheffield, S10 3TH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2025
First Posted
December 24, 2025
Study Start
December 16, 2025
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
May 1, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share