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.
Scientists said the use of psychedelic drugs to treat conditions such as depression could become a standard treatment within five years, with hopes that major strides can be made from just one session of “psychedelic-assisted therapy”.
Trials are underway using “short-acting” drugs that give patients a 20-minute psychedelic experience – which can include hallucinations – followed by a two-hour therapy session.Resetting brain networks
Experts said the approach appears to “reset the networks in the brain”, helping to end ingrained negative patterns of thought, and making patients far more receptive to therapy.
British company Small Pharma is leading the world’s first regulated clinical trial, which combines the hallucinogenic drug DMT (dimethyltryptamine) 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-one 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 in response to Brexit meant it was possible to accelerate the trial process, and ensure that drugs that showed promise were made available more quickly.
Following Britain’s exit from the European Union, the Medicines and Healthcare products Regulatory Agency (MHRA) created an “Innovative Licensing and Access Pathway (ILAP)” that aims 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 compounds found in “magic mushrooms” for treatment-resistant depression.Exploring the use of psychedelics
Meanwhile, 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 the treatment of mental health problems, 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 talking about 20 minutes, and then the integration therapy afterwards, in a total two-and-a-half-hour session … we expect the antidepressant activity 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 said existing data showed promising results.
The scientist said the treatment pathway works entirely differently to that of antidepressants.
“We think that this treatment will really get to the root cause, rather than just dampening symptoms, you really will get to the root cause. 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 … these ingrained patterns of thoughts in their neural connections”.
While the main class of antidepressants – SSRIs – “don’t really touch” such networks, psychedelics are thought to suppress such activity, making neural connections more flexible and increasing brain plasticity.
“You can reset those networks in the brain, and then that leaves the brain much more receptive to therapy, which is why we bring it in straight afterwards,” she said.Out-of-body sensations
In the trial, participants can expect to go through a psychedelic experience, which could include visual or aural hallucinations, and out-of-body sensations.
Dr Routledge said it was “absolutely feasible” that such therapy could become a first-line treatment for major depression.
“It will take a lot of educating and informing … there’s a lot of misconceptions about psychedelics, but they are like any medicine, as long as it’s the right dose, and the safety is controlled, with a therapist sitting next to you.”
She said the new access pathways set up by the MHRA in the wake of Brexit could speed up the journey, ensuring that promising innovative treatments reached patients faster.
“ILAP brings a lot of different organisations together, so you can have a real discussion about how you take your molecule forward. It’s really all about expediting the treatment to the patient.”