How psychedelic medication could open a new toolbox in mental health care

Biotech firms hope to cash in as new batch of drugs appear on the horizon to treat depression

Supportive science and clinical safety trials mean controversial treatment using psychedelic medication is edging towards US regulation. AP

Plant-based treatments and medication inspired by psychedelic drugs could soon treat depression in a new wave of acceptance for alternative therapy.

With 280 million people understood to suffer from depression worldwide, the global antidepressant market is expected to grow from $11.7 billion in 2019 to $18.3 billion by 2027, pharmaceutical analysts predict.

There has been a major overhaul of psychedelic medication used in alternative treatment for mental health conditions in recent years, as more supportive science and clinical safety trials edge the controversial drugs towards US regulation.

Stigma could yet be a major obstacle for psychedelic drugs to clear before they enter the mainstream, and in countries with stricter laws around medication they may never be approved.

Experts predict the US Food and Drug Administration could soon approve Methyl enedioxy methamphetamine (MDMA), a stimulant with psychedelic properties, as a treatment for post-traumatic stress disorder (PTSD).

Meanwhile, a variant of ketamine, commonly used as an animal tranquilliser, was granted FDA approval in 2019, also as a treatment for PTSD.

The US state of Oregon last year opened its first medical centre using psilocybin – the hallucinogenic compound found in so-called magic mushrooms – to treat various psychiatric conditions.

A major makeover in the way psychedelic medicines are viewed has opened the door for a number of biotech firms to tap into what could prove to be the next pharmaceutical gold rush.

Anti-depressant alternative

Toronto-based Cybin is one of those on a mission to transform mental health care in the US, where 13 per cent of Americans currently take selective serotonin reuptake inhibitors (SSRIs), the most commonly prescribed antidepressant that manages the brain’s feel-good chemicals.

“Psychedelics work extremely rapidly,” said Doug Drysdale, chief executive of Cybin, a company developing medication based on psilocybin.

“After a single dose, many patients are feeling a lot better. Anxiety disorders have a prevalence of about 19 per cent of the population, so collectively they are the largest mental health issue we're facing.

“A 90-minute experience might be enough to put patients in remission.”

The company has received clearance for its CTB004 drug, delivered under clinical observation via an inhaler or injection, after overwhelmingly positive results for phase-two trials in the treatment of depression.

Cybin is now pressing ahead with studies to prove preliminary clinical efficacy, safety and tolerability to allow it to be used in the wider population.

DMT, a hallucinogenic tryptamine drug found in plants, and psilocybin appear to provide rapid and large relief from depression after just a single dose, whereas SSRIs often take several weeks of a daily dosage to work effectively.

Those in trials described their psilocybin experience as “emotionally mystical and spiritual”, lasting for up to five hours.

Cybin’s study results showed 40 per cent of patients were in complete remission from depression at six months after only one or two doses.

“That's really powerful compared to what you see today, where we're really just trying to handle the signs and symptoms of mental illness,” said Mr Drysdale.

Other researchers found similar results. Published data from UK start-up Compass Pathways showed 29 per cent of trial subjects who received the highest dose of psilocybin were in remission, three weeks after treatment.

However, that did not last with only a quarter of those remaining free of depression three months later.

Not all mental health professionals are in agreement with the prospective new wave of treatments.

Marie Byrne, a psychological counsellor in Dubai, said mind-altering drugs were not the answer to helping people overcome mental challenges.

“It is possible to overcome the difficulties of trauma without having to be in an altered state of consciousness,” said Ms Byrne, who runs the Marie Wellness Clinic in Umm Suqeim.

“I have a real belief in what people are capable of and that's through counselling, step by step, to come to terms with things and connect with life, as opposed to wanting to live in an altered state of consciousness that doesn't allow them to address the real issue.

“If the actual problem that underlies depression is not addressed directly, it will resurface.”

Transforming perceptions

Attitudes towards alternative treatment methods appear to be changing.

Spravato, a nasal spray based on ketamine, has proved effective in those with treatment-resistant depression, although it is expensive and requires supervision.

Mark Rus is chief executive of Delix Therapeutics, a biotech firm in Boston developing novel therapeutic options for brain disorders that promise a new paradigm of neuroscience treatment.

“It's very hard to drug the brain or develop medicines that are safe, tolerable and effective,” Mr Rus told The National.

“That's why we’ve been stuck with the same class of treatments for decades.

“We've always talked about symptom management but we've never been able to consistently and predictably repair.

"You see all this promise and hype around psychedelics converging with these trends. It's a rich opportunity.”

Brain repairs

Delix Therapeutics focuses on neuroplasticity to regrow brain spines and synapses, working in a similar way to psychedelic medication but without hallucinations and cardiac risks.

“We hope that by 2027, DLX-001 will sit on the medicine cabinet at home and dispense from a pharmacy – we don't see anything in its properties or in our initial regulatory discussions that would prevent that," Mr Rus said.

“We don't believe this will be a once-a-day treatment and it is performing equivalently in terms of how fast they work and how long they last in preclinical models versus ketamine and psilocybin.

“There's a lot of people who can and will be helped by a classic, deep, eight-hour hallucinatory experience.

“But if you're going to move the needle and work at scale, you need approaches like Delix.”

Psychedelics work differently in each individual. Some have certain contraindications with psychotropic medication, while others do not. Some resonate more with the individual based on the person’s specific goals.

A contraindication is a situation where a specific procedure, medicine or surgery should not be used as it could be harmful to a patient.

Just as some people are visual learners and others are auditory, the psychedelic substance that is most effective often depends on the person.

Organic substances such as iboga, ayahuasca, San Pedro and psilocybin interact in a different way than LSD, ketamine and MDMA, for example. All are powerful and all have their role in healing, experts said.

Dr Jeff McNairy has been working in health care for 25 years and believes the western approach to healing and mental health is deficient.

He is chief medical officer at Rythmia Life Advancement Centre, described as a healing hub in Costa Rica where plants such as ayahuasca are used to treat wide-ranging mental health issues.

“The default mode network of the brain plays an important role in our self-perceptions and belief systems,” said Dr McNairy.

“When we have childhood trauma or unresolved emotional events that have shaped our coping styles, psychedelics allow the participant to access components of the subconscious through the interaction between the amygdala and prefrontal cortex of the brain.

“An ego-dystonic framework that is realised through the psychedelic experience allows the individual to 'become their own therapist' and see themselves from an outside perspective that can help build clarity and new levels of self-awareness.”

Set in luxurious surroundings, the Rythmia centre offers a programme fusing ancient South American tribal rituals with modern psychological practices.

But treatment comes at a price, with an all-inclusive seven-day cleansing experience costing $4,900.

“Some people do not qualify for certain psychedelics based on their medical condition,” said Dr McNairy.

“As with most of the world, there is a lack of understanding about what these substances can provide, how to manage them and the opportunity for research, biotechnology and true healing that can result from this field.”

Life-changing experience

A British man who visited the Netherlands for ayahuasca therapy said the results have been transformative.

“I decided trying ayahuasca with the aim of resolving my general feeling of inadequacies and insecurities dating back to childhood,” said the man, who did not want to be named.

“While I hadn’t taken any medication to resolve my symptoms, I had tried meditation and journalling, which had only partially helped.

“Ayahuasca is intense and it brought up many difficult memories and emotions, which I then processed during the ceremony. After I finished the retreat, I felt completely reborn and the recurring negative thought patterns completely disappeared.

“I look back on it as the most important experience in my life.’’

Mental disorders are one of the largest healthcare challenges of modern times.

They affect a huge number of people, with high treatment costs and lost productivity affecting economies.

An estimated 165 million are affected each year in the EU, with more than half the population of middle and high-income countries expected to experience at least one mental disorder during their lifetime.