World's first clinical trial for depression using psychedelic compound approved

The world’s first clinical trial to treat depression using a type of psychedelic chemical will begin its first phase next year.

Neuro-pharmaceutical company Small Pharma will work with the Imperial College London’s Centre for Psychedelic Research on a trial assessing how N,N-dimethyltryptamine (DMT) works in patients suffering from major depressive order.

DMT is a naturally occurring molecule with unique psychedelic properties underpinned by a similar pharmacology to psilocybin and LSD. It is a serotonergic psychedelic, meaning it induces a hallucinogenic response, and works by effecting serotonergic receptors in the brain including 5-HT2A, 5-HT1A, 5-HT2C and 5-HT7 receptors amongst others.

Small Pharma formed two years ago to explore the use of psychedelics in treating mental health conditions, specially looking at DMT as a potential compound. The company is aiming to develop a DMT-assisted therapy that acts as a novel rapid-acting sustained treatment for depression.The newly approved clinical trial will evaluate the combination of DMT and psychotherapy to treat patients with major depressive order. The first phase of the trial will start in January 2021 with the proof of concept (IIa) phase following shortly after.  

Carol Routledge, chief medical & scientific officer at Small Pharma, said: “This is a truly ground-breaking moment in the race to effectively and safely treat depression, as more and more people suffer as a result of the pandemic. At Small Pharma, we are committed to helping the millions of patients around the world who are losing hope in the search for a treatment for their depression, through advancement of this combination treatment.”

Peter Rands, CEO of Small Pharma said: “DMT delivers a psychedelic experience in 20 mins and has unique properties that lend itself to clinical use. By adopting responsible evidence-based research and development into psychedelic medicine, we hope to help rebrand these once stigmatised compounds as highly effective medical therapies, which can be integrated into current healthcare systems and made accessible to the millions of people suffering from depression.”