Psychedelic therapies could treat depression post-Brexit

Testing of ‘short-acting’ drugs to reset networks in brain approved under new UK medical regulations

BREXIT could lead to a boom in psychedelic therapies, scientists say.

A wave of companies have been approved to test the radical approach under new rules drawn up following Britain’s departure from the European Union. The use of psychedelic drugs to treat conditions such as depression could become standard within five years, with hopes that major strides can be made from just one session of “psychedelic-assisted therapy”.

Trials are underway using “shortacting” drugs, which give patients a 20-minute psychedelic experience and can include hallucinations, followed by a two-hour therapy session.

Experts said the approach appears to “reset the networks in the brain” helping to end ingrained negative patterns of thought, making patients far more receptive to therapy.

British company Small Pharma is leading the world’s first regulated clinical trial that combines the hallucinogenic drug dimenthyltryptamine (DMT) with psychotherapy in patients with major depressive disorder.

The trials, which are due to report their findings within months, involve 42 patients with the condition, and follow a phase I trial in healthy volunteers.

Dr Carol Routledge, chief medical and scientific officer at Small Pharma, said she was hopeful that such therapies could soon become a standard way to treat depression, in a way that “got to the root cause” of the problem, rather than simply masking symptoms.

She said changes in medical regulation after Brexit meant it was possible to accelerate the trial process, and ensure that drugs which showed promise were made available more quickly.

The Medicines and Healthcare products Regulatory Agency (MHRA) has created an “Innovative Licensing and Access Pathway (ILAP)” to speed up the time it takes to get new medicines to patients. Small Pharma’s trial has been granted an ILAP along with other companies testing MDMA combined with therapy for post-traumatic stress disorder (PTSD), and the use of the compounds found in “magic mushrooms” for treatment-resistant depression.

British start-up Clerkenwell Health is about to begin trials in the use of the same compound – psilocybin – to help people cope with a terminal diagnosis, and is exploring the use of psychedelics for depression and quitting smoking.

Dr Routledge said psychedelic drugs offered great promise in mental heath treatment, saying they could offer almost immediate benefits, compared with antidepressants, which often take up to three months to take full effect.

“Based on initial data that we already have, and other companies have, there’s going to be a fairly immediate impact,” she said, with results born of just one session. “In terms of the psychedelic experience, we’re taking about 20 minutes, and then the integration therapy afterwards – so in total a two-and-halfhour session, and we expect the antidepressant activity to be to be extremely durable... to last maybe three, four or five months,” she said.

The drug development expert said findings from current clinical trials were needed to demonstrate its efficacy, but existing data showed promising results.

The scientist said the treatment pathway works entirely differently to that of anti-depressants.

“We think that this treatment will really get to the root cause, rather than just dampening symptoms. That, potentially is the reason why these molecules will be so efficacious.”

Imaging data suggests that psychedelics work on the brain networks, in particular on the default mode network which is thought to be particularly active in depression.

“This links to the ruminative negative cycling, thought processes that lots of these internalising conditions have.”