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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDraig Therapeutics Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • DT-101

    Drug

    DT-101

  • Placebo

    Drug

    Placebo

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: DT-101Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
from enrolment to day 56

Secondary outcomes

1

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

Time frame
from enrolment to day 56

Other outcomes

Sponsors and contacts

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