A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression (Tarian-1)

April 30, 2026 updated by: Draig Therapeutics Ltd

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.

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. 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 Type

Interventional

Enrollment (Estimated)

300

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

  • Bulgaria
      • Kazanlak, Bulgaria, 6100
      • Plovdiv, Bulgaria, 4000
      • Sofia, Bulgaria, 1606
      • Vratsa, Bulgaria, 3000
  • Czechia
      • Ostrava, Czechia, 70868
      • Prague, Czechia, 10000
      • Říčany, Czechia, 25101
  • Poland
      • Gdansk, Poland, 80-952
      • Katowice, Poland, 40-156
      • Poznan, Poland, 60-835
  • United Kingdom
      • Chester, United Kingdom, CH2 1HX
      • Edinburgh, United Kingdom, EH16 4SB
      • Glasgow, United Kingdom, PA1 1JS
        • Not yet recruiting
        • Draig Clinical Site
        • Contact:
      • London, United Kingdom, SE5 8AF
      • Nottingham, United Kingdom, NG7 2TU
      • Oxford, United Kingdom, OX3 7JX
      • Sheffield, United Kingdom, S10 3TH
  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
      • Little Rock, Arkansas, United States, 72211
    • California
      • Oceanside, California, United States, 92056
      • San Diego, California, United States, 92103
      • Torrance, California, United States, 90502
    • Florida
      • Miami, Florida, United States, 33166
      • New Port Richey, Florida, United States, 34652
      • Orlando, Florida, United States, 32803
    • Georgia
      • Atlanta, Georgia, United States, 30331
      • Decatur, Georgia, United States, 30030
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
    • Mississippi
      • Flowood, Mississippi, United States, 39232
    • Nevada
      • Las Vegas, Nevada, United States, 89102
    • New Jersey
      • Marlton, New Jersey, United States, 08009
    • New York
      • New York, New York, United States, 10312
    • Pennsylvania
      • Media, Pennsylvania, United States, 19372
    • Texas
      • Austin, Texas, United States, 78737
      • Austin, Texas, United States, 78754
      • DeSoto, Texas, United States, 75115
      • Richardson, Texas, United States, 75243
      • Wichita Falls, Texas, United States, 76309
    • Washington
      • Bellevue, Washington, United States, 98004

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 A
Drug: DT-101
DT-101 A
Drug: DT-101
DT-101 B
Experimental: DT-101 B
Drug: DT-101
DT-101 A
Drug: DT-101
DT-101 B

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 42
Time Frame: from enrollment to day 42
from enrollment to day 42

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Clinician Global Impression of severity (CGI-S), at Day 42
Time Frame: From enrollment until day 42
From enrollment until day 42

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)

December 16, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DT-101/201

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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