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An Open-Label, Phase 2a, Single Dose Study to Evaluate the Safety Tolerability and Pharmacodynamics of BPL-003 in Patients with Treatment Resistant Depression

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Aims

Treatment resistant depression is a common and debilitating mental health problem, where new interventions are urgently needed.

With the support of Beckley PsyTech we are trialling 5-MeO-DMT given with structured psychological support for treatment resistant depression. 5-MeO-DMT is a short-acting psychedelic drug, which means that it induces an altered state of consciousness that can be characterised by mystical experiences, strong emotions, visions and distorted perceptions. 

Methods

This is a phase 2, open-label trial investigating 5-MeO-DMT given intranasally alongside structured psychological support for treatment resistant depression.

Participating in the trial

You need to have ongoing clinical depression that has not gotten better despite treatment, in order to participate in the trial. You will need to be able to travel to South London (Camberwell) to take part in the trial. We will be able to pay your travel expenses, but you will not be paid for participating in the trial.

There are strict inclusion and exclusion criteria for clinical trials. Please bear in mind the implications of being told that you can't take part: it could be very disappointing. For one reason or another, many people can't take part in clinical trials. 

Effects of Psychedelics

5-MeO-DMT is a short acting psychedelic which can have a very intense effect that comes on within minutes, then fades over the course of 30 minutes.

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’. You also need to bring a genuine motivation to change for the better, and to keep changing. 

Trials Design

Status

Open for recruitment

Participants

Adults

Clinical area

Treatment resistant depression

Intervention

5-MeO-DMT with Structured Psychological Support

Recruitment period

2023-24

Contact

5-MeO-DMT@kcl.ac.uk

Funder

Beckley PsyTech

Sponsor

Beckley PsyTech

Our Partners

Project status: Ongoing
Beckley_Psytech_Logo_high_res

Principal Investigator

Keywords

DEPRESSION5-MEO-DMTPSYCHEDELIC