A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression

NCT07610473 | Recruiting Phase 2 FDA Drug

• 1 other identifier: DT-101/202
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

Brief 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. A placebo looks the drug but contains no medicine. Subjects will attend the clinic for complete general health checks and to complete questionnaires.

Conditions

Major Depressive Disorder (MDD)

Keywords

MDD; Depression; DT-101; Randomized; Placebo Controlled; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56

  from enrolment to day 56

Secondary Outcomes (1)

• Change from baseline in Clinician Global Impression of severity (CGI-S), at Day 56

  from enrolment to day 56

Study Arms (2)

DT-101

EXPERIMENTAL

Drug: DT-101

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

DT-101 DRUG

DT-101

DT-101

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Draig Therapeutics Ltd: lead

Study Sites (2)

Draig Clinical Site

DeSoto, Texas, 75115, United States

RECRUITING

Draig Clinical Site

Miami, Texas, 33166, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Aeron-1 Clinical Team

CONTACT

+44(0)2920028450; info@draigtherapeutics.com

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: May 21, 2026
• First Posted: May 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)