The successful completion of Phase I of the world’s first clinical trial investigating the use of DMT-assisted therapy could lay the foundation for a “new paradigm” in the treatment of major depressive disorder.
The placebo-controlled trial demonstrated the intravenous formulation of N,N-dimethyltryptamine (DMT) – a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals – to be safe and well-tolerated in psychedelic naïve volunteers with no serious adverse events reported.
Carried out by neurpharmaceutical company Small Pharma, Phase I of the trial has now been completed and Phase IIa has begun, using a combination of psychotherapy and Small Pharma’s lead candidate, SPL026, for the treatment of major depressive disorder (MDD).
Emerging scientific evidence suggests DMT could have rapid-acting and long-lasting antidepressant effects. The command’s short psychedelic experience of less than 30 minutes could enable short treatment sessions and the potential for convenient supervised treatments within patient clinics.
Small Pharma CEO, Peter Rands, said: “We are delighted to have made such swift and excellent progress in the seven months since starting Phase I. The successful completion of Phase I means we can now truly assess SPL026 as a new potential treatment option for patients with MDD.
“There has been little innovation for patients suffering from MDD in the last few decades and SPL026 has the potential to change the mental health treatment landscape and provide a much-needed alternative therapy for patients.”
Dr Carol Routledge, Chief Medical and Scientific Officer of Small Pharma added: “We have achieved a significant milestone in the development of SPL026. With a strong safety and tolerability profile, now demonstrated, we can move ahead with the first regulated clinical trial of DMT-assisted therapy in patients.
“These results lay the foundation for Small Pharma’s DMT-assisted therapy as a potential new paradigm in the treatment of MDD.”
The dose-escalating Phase I study administered SPL026 in combination with supportive psychotherapy to 32 healthy volunteers who had no previous experience with psychedelics.
Small Pharma say it has generated a robust dataset on the pharmacokinetics of SPL026 – which elicits a breakthrough psychedelic experience – using Good Laboratory Practices as well as on safety and tolerability.
Phase IIa of the study, which is being held at two UK clinical trial sites, Hammersmith Medicines Research and MAC Clinical Research, will involve in 42 patients with MDD and will assess the efficacy of one versus two doses in combination with psychotherapy.
Small Pharma is advancing a pipeline of DMT-based therapies and is leading the clinical trial in collaboration with Imperial College London.
