Ketamine-Assisted Group Therapy for Spanish-Speaking Adults with Depression, Phase 1-2 Pilot Study

What this Trial Is About

Researchers are evaluating a ketamine-assisted group therapy for Spanish-speaking adults aged 18 to 64 with depression. This pilot clinical trial aims to assess whether this culturally adapted group intervention is feasible and safe in a community setting while also exploring its preliminary effects on psychiatric symptoms, wellbeing, and health behaviors. Participants must meet criteria for major depressive disorder and have moderate to severe symptoms based on a depression scale. The study involves an open-label, single-arm design where all participants receive ketamine-assisted psychotherapy delivered in a group format. The treatment is tailored specifically for Spanish-speaking adults and is provided under medical supervision. There is no placebo or comparison group in this phase 1 and 2 study. Participants will be observed and evaluated over several weeks, with key assessments occurring one week after treatment to measure feasibility and safety, and follow-up evaluations at one and twelve weeks post-intervention to examine changes in depression symptoms and overall health. Safety monitoring includes clinical evaluation by a psychiatrist and assessments related to medical history and vital signs. The total participation period extends through these follow-up visits to collect comprehensive data on the interventions impact.

A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression