DMT (N,N-Dimethyltryptamine) is a potent hallucinogenic drug that occurs in many plants and animals. It is commonly used as a psychedelic drug and prepared by different cultures for ritual ceremonies as an entheogen. This drug can be ingested, inhaled or injected.
A recently concluded trial has found that DMT may be useful in the treatment of major depressive disorder (MDD). Major depressive disorder refers to a mood disorder that causes an individual to lose interest in activities that usually elicit joy; the mood also results in persistent sadness.
The study was conducted by Small Pharma, a company focused on the treatment of a range of mental health conditions using psychedelic-assisted treatments. The company carried out a phase 2a trial of its pharmaceutical-grade formulation of DMT, dubbed SPL026. The objective of the trial was to evaluate how safe and effective it was to administer 21.5 mg of the SPL026 proprietary formulation intravenously, in conjunction with supportive therapy.
During the study period, 34 patients who had been diagnosed with major depressive disorder were recruited and received the drug during their sessions. The trial occurred in two stages. The first stage lasted two weeks and was placebo-controlled and randomized while the second stage was open label. This meant that each patient received SPL026 as part of their treatment and were observed for three additional months.
After the initial three-month period had lapsed, patients were observed for another six months to identify how long the drug’s effect lasted. The researchers, using the MADRS scale, determined that about 64% of patients who achieved remission were able to maintain it for six months.
In a statement, the company’s chief medical and chief scientific officer Dr. Carol Routledge noted that the team was encouraged by SPL026’s treatment potential. Routledge revealed that the findings would help inform the researchers’ approach to patient retreatment and their understanding of treatment durability within the next phase of their trial.
Director of the Weill Institute for Neurosciences—Psychedelics Division Dr. Robin Carhart-Harris commented that the data had shown that SPL026 could induce a fast-acting antidepressant response that appeared to be lasting in some cases. Carhart-Harris also holds the Ralph Metzner Distinguished Professorship in Neurology, Psychiatry and Behavioral Sciences.
While the study’s findings suggest that the formulation may be an effective and safe therapy option for major depressive disorder, larger trials are needed to confirm these results before the company can submit its application to the FDA for approval.
Additional research is ongoing by companies such as Field Trip Health Ltd. (OTC: FTHWF) (TSX: FTHW) studying how different psychedelic compounds can help in the treatment of mental health disorders. As these efforts yield positive results, the mental health field is likely to undergo a major shift in the way patients are treated.
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