Regulators in the UK have given the green light for a psychedelic drug to tested as a treatment for depression alongside psychotherapy.

Scientists will conduct the first clinical trial of the use of the psychedelic drug dimethyltryptamine (DMT) to treat depression. DMT is known as the “spirit molecule” because of the powerful hallucinogenic trips it creates in users.

Approval to undertake the trial was given this month by the Medicines and Healthcare products Regulatory Agency (MHRA), but now the Home Office need to approve the study as DMT is a controlled substance.

It will be given to two groups, healthy individuals and then a second trial is expected in people with depression alongside psychotherapy.

People with diabetes are three times more likely to be diagnosed with depression than those without it, according to NICE. Depression can have a major impact on well being and the ability and motivation of a person to self-manage their condition.

Small Pharma is the firm running the trial in partnership with Imperial College London. The company’s chief scientific and medical officer Carol Routledge said: “The psychedelic drug breaks up all of the ruminative thought processes in your brain – it literally undoes what has been done by either the stress you’ve been through or the depressive thoughts you have – and hugely increases the making of new connections.

“Then the [psychotherapy] session afterwards is the letting-things-settle piece of things – it helps you to make sense of those thoughts and puts you back on the right track. We think this could be a treatment for a number of depressive disorders besides major depression, including PTSD, treatment-resistant depression, obsessive-compulsive disorder, and possibly some types of substance abuse.”

It is hoped the initial trial, which could start in January, will establish the lowest dose of DMT that elicits a psychedelic experience. There will be 32 healthy participants, who have not previously taken a psychedelic drug. This will be followed by a study involving 36 people diagnosed with clinical depression.

The Beckley Foundation, based in Oxfordshire, designs and develops psychedelic drug research to inform global drugs policy.

It’s founder and director Amanda Feilding said: “I myself don’t find DMT to be a very lovable compound, but it is definitely an interesting study to do. It is a harsher compound than other psychedelics like psilocybin or LSD, where the experience is more like a flower opening and receiving what’s already inside you.

“DMT triggers a strong [psychedelic trip], where people experience what they call ‘the entities’ – they meet beings who seem to be real, like being in a dream. But it can rather take one over.”

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