A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression
Part of paid clinical trials in DeSoto, Texas.
- Sponsor
- Draig Therapeutics Ltd
- Study ID
- NCT07610473
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Major Depressive Disorder (MDD)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- DT-101 — DRUGDT-101
- Placebo — DRUGPlacebo
Study Details
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.
Key Dates
- Start date
- May 31, 2026
- Status verified
- May 2026
- Primary completion
- May 31, 2027
- Completion
- May 31, 2027
Study Design
- Enrollment
- 118 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: DT-101
- Placebo Comparator: Placebo
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 ]
Central Contacts
- Aeron-1 Clinical Team+44(0)2920028450
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Draig Clinical Site | DeSoto | Texas | 75115 | |
| Draig Clinical Site | Miami | Texas | 33166 |
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