A psychedelic drug that gives trips lasting half an hour improves the symptoms of moderate to severe depression for up to six months, early trial results suggest.
Biotechnology company Small Pharma announced the results of its phase 2a clinical trials of the effects of a pharmaceutical-grade formulation of Dimethyltryptamine (SPL026) on major depressive disorder, simply referred to as depression.
The drug is a powerful hallucinogenic found in several plants and can be smoked, snorted or mixed with ayahuasca.
These data indicate that SPL026 can elicit a fast-acting antidepressant response that appears to be enduring in several cases— Robin Carhart-Harris and Ralph Metzner, UCSF
In the study, 34 patients were given the drug during a clinical session with supportive therapy.
The individual sessions lasted less than two-and-a-half hours, and included a preparation session with a therapist, a psychedelic experience (where the therapist was present) lasting less than 30 minutes, and a therapy session to help patients process their trip.
According to data from the trial, among the patients who had achieved remission within three months of taking the drug, 64% sustained remission to six months.
Robin Carhart-Harris, director of the psychedelics division at the Weill Institute for Neurosciences at the University of California San Francisco, and Ralph Metzner, distinguished professor of neurology, psychiatry and behavioural sciences, said: “These data indicate that SPL026 can elicit a fast-acting antidepressant response that appears to be enduring in several cases.
“Recent neuroimaging and preclinical findings imply a regenerative action with DMT and other related serotonergic agonists.”
The trial investigated the effectiveness and safety of 21.5mg of SPL026 given intravenously with supportive therapy in 34 patients with moderate or severe depression.
The study was carried out in two stages – the first aimed to assess the efficacy of a single dose of SPL026 with supportive therapy, and in the second patients received SPL026 treatment, and were followed up for a further three months in study.
They continued to be followed up out of study to six months after the second stage, enabling further assessment of the durability of the antidepressant effect.
A total of 25 patients from both treatment arms completed the six-month patient follow-up.
According to the results announced on Tuesday, which have not been peer-reviewed, of these patients, 14 had initially achieved remission (considered to be no depression, or very mild depression) within the three-month in-study period.
Nine of these people sustained remission at six months.
Given these clinical outcomes from one or two treatments, this could further offer potential value to healthcare systems that face challenges with patients who struggle to adhere to their daily antidepressant use— George Tziras, Small Pharma
Dr Carol Routledge, chief medical and scientific officer, said: “With our ongoing analyses of the Phase IIa trial data, we are increasingly encouraged by the treatment potential of SPL026.
“A single dose in conjunction with therapy demonstrated a rapid and robust antidepressant effect after one week.
“This new data shows that the antidepressant effect was sustained for six months in two-thirds of patients who were in remission at an earlier time-point in the study.
“As we finalise the design of the Phase IIb study, this data helps to inform our understanding of treatment durability and our approach to patient retreatment within the trial.”
George Tziras, chief executive of Small Pharma, said: “We are pleased to see that participants in our study experienced durable relief from their depression for an extended period of time.
“Given these clinical outcomes from one or two treatments, this could further offer potential value to healthcare systems that face challenges with patients who struggle to adhere to their daily antidepressant use.”
