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
Qualifiers
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
Treatments tested in this trial
- DT-101
- DT-101
- Placebo
Treatment groups
300 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov