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 — DRUG
    DT-101
  • Placebo — DRUG
    Placebo

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

Locations (2)

FacilityCityStateZIPSite coordinators
Draig Clinical SiteDeSotoTexas75115
Draig Clinical Site
+44(0)2920028450
Draig Clinical SiteMiamiTexas33166
Draig Clinical Site
+44(0)2920028450

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