A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression
ConditionMajor Depressive Disorder (MDD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDraig Therapeutics Ltd
About this trial
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. Subjects will attend the clinic every couple of weeks complete general health checks and complete questionnaires.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
DT-101
DrugDT-101 A
DT-101
DrugDT-101 B
Placebo
DrugPlacebo
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: DT-101 AExperimental treatment 1 intervention
Group B: DT-101 BExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 42
Time frame
from enrollment to day 42Secondary outcomes
1
Change from baseline in Clinician Global Impression of severity (CGI-S), at Day 42
Time frame
From enrollment until day 42Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov