UK neuro-pharmaceutical company Small Pharma said that they have gained regulatory approval in early December 2020 to launch the world’s first patient clinical trials using dimethyltryptamine (DMT) to potentially treat depression and isolate the root cause of the ailment, Pharmafield reported.
The company is set to start the initial trial for this month, after receiving the go-ahead from the Medicines and Healthcare products Regulatory Agency (MHRA).
Two years ago, the London-based company had recognized the potential of psychedelic drugs to provide fast and enduring treatment for an array of mental health disorders, particularly depression, according to Pharmafield. Small Pharma aims to explore the therapeutic properties of DMT-assisted treatment in the newly approved trial.
“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,” said Carol Routledge, Chief Medical & Scientific Officer at Small Pharma.
According to the Guardian, the first phase will help the company determine the minimum dosage required to induce a psychedelic experience.
Small Pharma will be collaborating with Imperial College’s Centre for Psychedelic Research in a two-pronged trial. Part A will first involve administering DMT to 32 healthy volunteers who are “psychedelic naïve,” in other words, those who have never taken psychedelic substances before. In Part B, researchers will give DMT to 36 patients with clinical depression, and the treatment will be coupled with psychotherapy, according to the Guardian.
“We are working closely with this world-leading psychedelic research group as we conduct our first randomised controlled, placebo-controlled Phase I/IIa trial of DMT-assisted therapy in both healthy volunteers and patients in London,” Small Pharma’s website reads.
Also known as the “spirit molecule,” DMT elicits potent hallucinogenic trips and is found in plants and animals. It disconnects the brain’s ruminative thoughts and enhances new connections in the brain, Routledge told the Guardian. She likened taking DMT before therapy to shaking a snow globe and letting the flakes settle.
“We hope to help rebrand these once stigmatized compounds as highly effective medical therapies,” Rands said, “Which can be integrated into current healthcare systems and made accessible to the millions of people suffering from depression.”
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