King's College London

The effects of treatment resistant depression (TRD) can be extremely debilitating and current treatments aren’t always effective. Working with Beckley Psytech Ltd as part of a multi-centre trial, King’s researchers are investigating the safety and efficacy of BPL-003 (a synthetic formulation of 5-MeO-DMT) for people with TRD. 

The main purpose of this study is to study the effectiveness, safety, and tolerability (whether side effects occur and how severe they are) of BPL-003. This study also aims to find out how participants react to different doses of BPL-003, what they are experiencing, and how well the psychological support that will be provided by trained psychotherapists will prepare and guide participants through the treatment session. Another purpose of this study is to measure the effects that BPL-003 has on the body in terms of how the body absorbs, distributes, and removes the study medication (called pharmacokinetics or PK). 

If you are enrolled in the trial, you will be randomised to receive either 0.3mg, 8mg or 12mg of BPL-003. There will also be the option to take part in an Open Label Extension. 

This is a Phase 2 study randomized, quadruple masked, multi-center study designed to investigate the efficacy and safety of a single dose of BPL-003 combined with psychological support in patients with treatment resistant depression (TRD).

Participating in the trial

If you wish to volunteer for this trial, please consider your decision carefully. There are strict inclusion and exclusion criteria the team cannot deviate from. You will be usually asked to attend the research facility on numerous occasions, without much flexibility for variation in dates. Clinical trials are not the same as receiving treatment from your doctor or therapist. We use placebos or variable doses in some of our trials. You may not get the treatment you want and the team is unable to change this, for any reason.

For one reason or another, most people who volunteer turn out not to be eligible for a clinical trial. It’s important to be realistic about the chances of inclusion and pursue other sources of help at the same time.

Effects of Psychedelics

Depending on the drug, psychedelic therapy lasts from about 1 to 8 hours. We only give people psychedelics in a dedicated hospital facility with support from doctors, nurses, psychotherapists and study coordinators. We don’t give people psychedelics to take home.

It isn’t possible to predict how psychedelics will affect an individual person. Clinical trials are an experiment. They are being done because we do not yet know if psychedelic therapy is a safe and effective form of treatment. Therefore, your participation in a trial comes with some risks. Your condition could improve, stay the same or it could worsen. Psychedelic therapy is not a ‘reset’ for your brain and it is not a ’quick fix’. Regardless of what happens, it’s important to have the right support around you if this happens. There are limits to the extent the study team can support you, particularly out of normal office hours.