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Phase 1 Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans

The goal of this phase 1 study is to investigate the safety and efficacy of dimethyltryptamine (DMT) in individuals with depression and healthy controls. We hypothesize that administration of DMT will result in decreases in depression, associated symptoms, and neuroplastic changes in depressed subjects. We expect that DMT will induce changes in neuroplasticity as indexed using electroencephalographic (EEG) measures and tasks in both depressed individuals and healthy volunteers, though to different degrees. These neuronal changes may in parallel cause changes in mood measured both in healthy and depressed subjects, which will be captured using appropriate psychometric measures of mood.

Status
recruiting
Phase
Phase 1
Institution
Deepak C. D'Souza
Principal investigator
Deepak D'Souza, MD
Start date
2025-03-14
End date
2027-12-01
Registry ID
NCT06671977

View trial record

Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.