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Centre for Affective Disorders

Psilocybin Trials

The Psychedelic Trials Group at the Centre for Affective Disorders is currently running randomised, controlled trials of psilocybin. These trials are led by Dr James Rucker and Professor Allan Young.

The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (P-TRD)

We are looking for people over the age of 18 with current depression that has not responded to the usual antidepressant treatments. Psilocybin is a controlled drug and one of the ingredients of so-called ‘magic mushrooms’. Recent research has suggested that psilocybin may help in treating depression and we wish to investigate this further. For more information contact psilocybin@kcl.ac.uk

Psilocybin in Depression Resistant to Standard Treatments (PsiDeR)

This study does not yet have regulatory approval, however we are anticipating a start date of around November 2019. You can also register your interest at psilocybin@kcl.ac.uk

The Effects of Psilocybin on Cognitive Function in Healthy Participants

We have recently completed a study to test the effects of Psilocybin on cognitive function. Cognitive function is the way the brain processes knowledge, memory, judgement and problem solving. The most recent studies have indicated that psilocybin might facilitate improvement on cognitive function; however, these effects have not been fully evaluated and we are investigating this further. We are no longer recruiting for this study, but to register interest in any future studies with healthy participants, please email psilocybin@kcl.ac.uk 

The History of Psychedelics in Psychiatry

Prior to 1970, and the UN Conventions on Drugs, the classical psychedelics psilocybin, mescaline and d-lysergic acid diethylamide (LSD) were used as treatments in psychiatry for resistant forms of depression, anxiety and addictions. Research at that time, which was suboptimal by modern standards, suggested that they may help some people who were psychologically ’stuck’ in the process of therapy to attain new perspectives on their difficulties within a safe and psychologically supportive context. This, in turn, could lead to enduring, positive behavioural change with ongoing support. Delivered within a medically controlled environment and with a trusted therapist, the risk of serious adverse events was observed to be low. However, the classical psychedelics were thought not to be safe for people with psychotic disorders such as schizophrenia, or for people who were predisposed to developing these conditions.

After 1970, caught up in the US-led ‘war on drugs’, LSD, psilocybin and mescaline were designated ‘Schedule 1’ substances in the UN Conventions on Drugs, meaning that they could not be prescribed by medical doctors outside of an authorised research study. Funding for such studies dried up in the wake of hardening socio-political attitudes towards psychoactive substances. As a consequence, this area of clinical research in psychiatry came to a standstill without a clear view about whether the drugs were safe and effective when compared to placebo or other treatments.

After a 30 year pause there has been a slow but steady resurgence of clinical research interest into psilocybin, which is the active component of so-called ‘magic mushrooms’. An open label pilot study of psilocybin delivered with psychological support to 20 patients with difficult-to-treat depression suggested that this paradigm of treatment was feasible when delivered in a medically controlled setting. This is now being investigated further through the current trials at the Centre for Affective Disorders.

The Need for New Paradigms of Treatment in Psychiatry

Whilst many patients with mental health problems respond well to currently available treatments, there remain a subgroup of people with difficult-to-treat, or ‘treatment resistant’ forms. Historically there has been relatively little to offer them except ‘more of the same’. Mental health problems are common, and treatment resistant mental health problems are particularly disabling, leading to personal burdens, burdens on carers and family and wider society. But historically this group has also been under-researched relative to other less common conditions. Treatment resistance is associated with higher rates of suicide and worsens outcomes in a wide variety of other health problems.

How Psilocybin Works

Treatment with psilocybin is hypothesised to help ‘loosen’ the habitual patterns of thinking and behaviour that underpin forms of treatment resistant depression, anxiety, obsessions, compulsions, post-traumatic stress, addictions, eating disorder and personality difficulties. Psilocybin works on the serotonin system, ‘relaxing’ the brain mechanisms that mediate thought and behaviour. As this happens, old patterns ‘dissolve’ and a therapeutic ‘window of opportunity’ is introduced. Patients receiving psilocybin describe it as like a ‘waking dream’, with new insights and understanding emerging about why they are suffering. This can sow a psychological ‘seed of change’. Our therapists then work with patients to help them solidify more helpful perspectives on their difficulties, including a plan of what they are going to do on an ongoing basis to change their lives for the better. Psilocybin does not work for everyone, but our initial pilot work has been encouraging, with some patients reporting enduring, positive benefits from only a single treatment dose of psilocybin with no ongoing need for daily medication. Experiences under psilocybin are not dangerous, but can be psychologically challenging because strong emotions or memories may arise. This underlines the need for a safe environment and a trusting relationship with an experienced therapist.

The History of Human Use of Psilocybin

Psilocybin in the form of mushrooms has been used for thousands of years by different cultures in ceremonial and healing rituals. We now know that psilocybin gently stimulates the serotonin system in the brain and it is this effect that leads to the ‘waking dream’ state that people report. This lasts for about 4-6 hours, after which people find they arrive back to their usual state of mind and can go about their business as usual. We only give people psilocybin in a dedicated hospital facility with full support from doctors, nurses and psychotherapists. We never give people psilocybin to take home. The psilocybin used in our trials is not derived from mushrooms. It is manufactured to the same standard as any medicine prescribed by your doctor.

General Information

The Centre for Affective Disorders at King’s College London was awarded a large grant from the National Institute for Health Research (NIHR) in 2017 to investigate the safety, feasibility and efficacy of psilocybin as a treatment for clinical depression that has not improved with standard treatments, using the gold standard design of a randomised, placebo-controlled trial. This study will be led by Dr James Rucker and, subject to trial approvals, will recruit up to 60 participants with current depression unresponsive to the usual treatments.

The aim of the research is to determine whether psilocybin delivered with psychological support and medical supervision is a safe treatment for people with difficult to treat depression. To determine this, the trial will collect detailed data on adverse events as well as comparing participant’s ratings of their depression symptoms before and after treatment and between different doses of psilocybin. We will also investigate which form of psychological support best meets the needs of those receiving psilocybin and whether we can use cognitive tests, blood tests and brain scans to understand how psilocybin works in the brain and who it might suit best.

The Centre has also been awarded funding from a commercial life sciences company, COMPASS Pathways Ltd., to undertake a study of the effects of psilocybin on cognitive and emotional processing in healthy volunteers.  The Centre is also participating in COMPASS’ international randomised controlled trial of psilocybin for difficult-to-treat depression that is taking place in multiple centres throughout Europe. Recruitment will start in Summer 2019.  Both studies will be led by Dr James Rucker and Prof. Allan Young.

 

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