World's first clinical trial for DMT-assisted therapy in Major Depressive Disorder completes Phase I

Phase I of the world’s first clinical trial for dimenthyltryptamine (DMT)-assisted therapy in Major Depressive Disorder (MDD) is now complete. The neuroscience company behind the research, Small Pharma Inc., is sharing the results and analysis of this first phase, and expects to deliver results for Phase II in the first half of 2022. 

The Phase I trial involved 32 healthy volunteers who were “psychedelic naïve,” meaning they had no prior use of psychedelic drugs.  The volunteers  received either four increasing doses of Small Pharma’s SPL026 (DMT Fumarate) compound in combination with psychotherapy, or a placebo. The analysis gave insight into safety and tolerability, as well as treatment experience and subject well-being.

Key findings include:

• In a three-month follow-up, no statistically significant negative effects were identified in regards to anxiety and well-being. 
• Data show a clear correlation between quality of psychedelic experience and dosing level.
• There appeared to be a strong connection between levels of DMT in the body and the quality and intensity of the psychedelic experience for the majority of participants.
• IV administration of the drug offers a short-lived, well-tolerated psychedelic experience of ~20 minutes, enabling a dosing session to last only ~30 minutes.

Notably, both patient-reported scores and therapist predictions of expected benefits showed a correlation between the size of the dose and the quality of the psychedelic experience.

No serious adverse events related to the drug occured, and the adverse events that were reported on the day of dosing were minimal and short-lived.The 30 drug-related adverse events noted were mild or moderate and resolved quickly and independently. Testing showed that the drug cleared out of the body quickly, with near undetectable DMT levels in the blood an hour at all investigated doses. 

“Psychedelic-assisted therapies have the potential to completely change the treatment paradigm of mental health conditions. The additional insights from Small Pharma’s Phase I study show promising results at this stage of the development,” David Erritzoe of Imperial College London, Chief Investigator of the Phase I/IIa study said in a release. “The dosing time of 30 minutes, in comparison with up to six hours seen with alternative approaches, has the potential to offer a real benefit in terms of treatment regimen for both patients and providers.”

Phase IIa of the study remains on track to deliver results in the first half of 2022. It will involve a blinded, randomized, placebo-controlled, proof-of-concept study of SPLO26, combined with psychotherapy in 42 patients with MDD. 

Although it might be a while until DMT receives FDA approval in the United States, the results of this Phase I study shows the promise of this compound potentially being the latest tool to help improve mental health.