This open-label, early Phase I trial (n=10) will assess the feasibility, safety, and preliminary efficacy of ketamine-assisted group therapy for Spanish-speaking adults with depression.
Conducted by Dr. Juliana Zambrano at Massachusetts General Hospital, the study aims to evaluate a culturally adapted group-based intervention for Latino participants aged 18–64 with major depressive disorder.
Participants will receive ketamine-assisted psychotherapy in a group format, with preparatory, dosing, and integration sessions. The trial will measure attendance and adherence rates, as well as participants’ perceptions of the intervention. Safety will be assessed through vital sign monitoring and adverse event evaluations, while efficacy will be examined through changes in psychiatric symptoms, wellbeing, and health behaviours. The study is expected to begin in January 2025 and conclude by July 2025.
Trial Details
This is a pilot clinical trial to assess the feasibility, safety, and preliminary efficacy of ketamine-assisted group therapy for Spanish-speaking adults with depression.Trial Number NCT06597695
Sponsors & Collaborators
Massachusetts General HospitalMassachusettes General Hospital has launched the MGH Center for the Neuroscience of Psychedelics. The announcement has now been done via YouTube, and the formal launch will be in fall 2020.