A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression (NCT07300969) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression
United States300 participantsStarted 2025-12-16
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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, 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).
Exclusion Criteria:
* 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.
* History of seizure.
* In the investigator's opinion, the participant is not capable of adhering to the protocol requirements.
What they're measuring
1
Change from baseline in total Montgomery Ă…sberg depression rating scale (MADRS) score, at Day 42