Study of Antidepressant Effects of DMT With and Without Propofol Sedation in Major Depression

What this Trial Is About

Researchers are investigating whether the antidepressant effects of N,N-dimethyltryptamine DMT in people with major depressive disorder MDD come from biological changes like brain plasticity and reduced inflammation or from the psychedelic experience itself. This study focuses on adults diagnosed with moderate to severe depression and compares DMTs effects with and without the psychedelic experience by masking it using sedation with propofol. Participants will be randomly assigned to one of four groups DMT with sedation, DMT without sedation, placebo with sedation, or placebo without sedation. The DMT or placebo is given as a 20-minute infusion, while sedation with propofol lasts 30 minutes when used. This design allows researchers to understand if the psychedelic experience is necessary for antidepressant effects or if biological mechanisms alone are responsible. During the study, participants will be assessed for changes in depressive symptoms using several scales at various times up to 14 days after treatment. Researchers will also monitor anxiety, quality of life, psychedelic effects, safety events, and biological markers like neuroplasticity and inflammation. The study includes baseline and follow-up evaluations, mood and personality assessments, and sedation level monitoring, offering a thorough picture of DMTs impact on depression over time.

Antidepressant Response of DMT Masked With Propofol