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DT-101

Phase 2

Major Depressive Disorder (MDD) | Small molecule | Psychiatry |cbdMD, Inc.|Last Updated: Aug 26, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

DT-101 · 1 trial · 1 indication

Phase 2 1
NCT07300969A Study to Evaluate the Effectiveness of DT-101 in Patients With DepressionMajor Depressive Disorder (MDD)
RECRUITING300 Analytics
PHASE2RECRUITING
A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression
Major Depressive Disorder (MDD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 42
from enrollment to day 42

Secondary Endpoints

Change from baseline in Clinician Global Impression of severity (CGI-S), at Day 42
From enrollment until day 42
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DT-101 AEXPERIMENTAL -
DT-101 BEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
DT-101DRUGDT-101 A
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites43

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, incl...

Countries:United StatesBulgariaCzechiaPolandUnited Kingdom
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