Small
Pharma conducted Phase IIa clinical trials of its drug SPL026, a
pharmaceutical-grade formulation of the psychedelic drug
Dimethyltryptamine (DMT), to assess its effects on major depressive disorder.
In
the study, 34 patients with moderate to severe depression were given
the drug in a clinical session with supportive therapy, consisting of
preparation, psychedelic experience, and therapy to process the trip.
- The psychedelic experience lasted less than 30 minutes, and the individual sessions lasted less than two and a half hours.
- The trial showed that 64% of patients who achieved remission within three months of taking the drug sustained it to six months.
- The
drug elicited a fast-acting antidepressant response that appears to be
enduring in several cases, with regenerative action suggested by recent
neuroimaging and preclinical findings.
- The study investigated the effectiveness and safety of 21.5mg of SPL026 intravenously with supportive therapy.
- The
study was carried out in two stages, the first to assess the efficacy
of a single dose of SPL026 with supportive therapy and the second to
follow up on patients for a further three months.
- The results have not been peer-reviewed and will help inform the design of the Phase IIb study.
