Safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of intravenous dosing of SPL026 drug product (N, N-dimethyltryptamine fumarate; DMT Fumarate [A Serotonergic Psychedelic]) alone or in combination with selective serotonin reuptake inhibitors in patients with major depressive disorder

This interventional trial (n=24) will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory efficacy of DMT (SPL026), a serotonergic psychedelic drug, alone or combined with selective serotonin reuptake inhibitors (SSRIs) in patients with major depressive disorder (MDD).

Major depressive disorder, commonly known as depression, affects around 280 million people globally, manifesting in various symptoms such as unhappiness, hopelessness, and physical ailments. Current treatments often fall short, prompting the need for alternative options. SPL026, also known as DMT, acts on serotonin receptors in the brain and is being explored as a potential treatment when combined with therapy sessions. Previous research on similar psychedelics like psilocybin suggests promising results in treating depression alongside therapy. The study aims to evaluate the safety, absorption, removal, and effects of SPL026 on patients already taking SSRIs compared to those not taking SSRIs.

Up to 24 patients with mild to severe MDD will participate, divided into two groups: those currently taking ineffective SSRIs and those not on any medication for depression. Participants will receive a single dose of 27.5 mg DMT via intravenous infusion, accompanied by psychological support from a therapist team. The psychedelic experience typically lasts around 20 minutes and includes visual hallucinations, changes in perception, and intense emotions. Expert therapists will guide participants through the experience, ensuring safety and providing support. Potential risks include temporary physical effects and the possibility of challenging emotional experiences, which therapists will assist in managing. Participants will be closely monitored throughout the study, with precautions taken to address any adverse reactions.

The trial is sponsored by Cybin UK Ltd., with funding from Cybin IRL Ltd., based in Ireland. The study, conducted from April 2022 to August 2023, aims to contribute to medical research in treating depression using innovative psychedelic therapies.

Trial Details

This trial, conducted by Cybin UK Ltd., investigates the safety and efficacy of SPL026, a psychedelic drug, alone or combined with SSRIs, in treating major depressive disorder (MDD). It involves 24 participants with MDD, assessing the drug's effects and safety through intravenous administration of a single dose of 27.5 mg DMT. The study aims to provide an alternative treatment option for depression and contributes to ongoing research in psychedelic therapies.

NCT Number ISRCTN10974027

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