Clinical trials firm accelerates research using psychedelic drug DMT for depression

Trials in progress
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A North West clinical research company has been appointed to co-lead new research to develop treatments for depression after UK regulators gave approval for the first clinical trial to explore the psychedelic drug dimethyltryptamine (DMT) with therapy in patients.

MAC Clinical Research – one of Europe’s largest independent clinical development firms – has been selected by London-based neuropharmaceutical company, Small Pharma, to accelerate research for its lead product to test for effectiveness in major depressive disorder (MDD).

MAC is based in Blackpool, but has dedicated hubs in Manchester and Liverpool.

The Medicines and Healthcare products Regulatory Agency (MHRA) approved the trial in December 2020, with its first phase that took place at Hammersmith Medicines Research (HMR) now complete.

MAC will now work with HMR to shape the trials’ second stage and explore the use of DMT-assisted therapy at its bespoke facility for psychedelic research in Liverpool, one of only three of its kind in the UK.

The trial will see patients take part in preparation sessions with the therapists before they are dosed DMT.

Patients will be supported during the experience and provided with integration sessions once the psychedelic experience ends.

Dr Mark Dale, chief executive at MAC Clinical Research, said: “We’re excited to be collaborating with Small Pharma on the safety and efficacy of DMT-assisted therapy in patients with moderate or severe MDD.

“We are looking forward to being a part of developing DMT in combination with psychotherapy as a potential treatment for mental health disorders.”

He added: “Psychedelic treatments have been shown to have therapeutic benefits in disorders such as depression, substance abuse and post-traumatic stress disorder.

“Clinical research suggests that DMT can disrupt the neuronal pathways that underlie negative thought processes, and by doing so may facilitate the benefits of therapy given in combination with DMT.”

Peter Rands, CEO of Small Pharma, said: “We’re pleased to now be progressing this study into its second phase.

“MAC’s extensive clinical practice experience, expertise and infrastructure will provide us with more access to additional sites designed for psychedelic clinical trials such as ours.

“This means we can work with more patients and accelerate our timelines to deliver proof of concept for our lead product, DMT.”

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