BPL-003 – Treatment Resistant Depression Monotherapy Study
Research type
Research Study
Full title
An Open-Label, Phase 2a, Single Dose Study to Evaluate the Safety Tolerability and Pharmacodynamics of BPL-003 in Patients with Treatment Resistant Depression
IRAS ID
1005898
Contact name
Ian MacLeod
Contact email
Sponsor organisation
Beckley Psytech Ltd
Eudract number
2022-002502-24
Clinicaltrials.gov Identifier
Research summary
This is a study of 5-MeO-DMT (BPL-003; the study drug) – a psychedelic substance that occurs naturally in some plants and animals. We’re testing a new form of 5MeO-DMT, called BPL-003 as an experimental new medicine for treatment resistant depression (TRD).
Depression is a common mental illness that affects more than 350 million people worldwide. There are existing treatments for depression, but they do not work well in all patients. About a third of patients have TRD, meaning their depression does not respond to at least 2 commonly available treatments.
BPL-003 stimulates the serotonin system in the brain. The serotonin system is known to regulate mood and a sense of wellbeing. Other treatments for depression also stimulate the serotonin system, but the study drug we are testing does this in a different way to usual. Our theory is that the study drug, when used alongside talking therapy (also called psychotherapy) will provide relief from depression for patients for whom other treatments have not worked.
This study aims to find out the side effects and experience when taking the study drug with psychotherapy, and if it improves patients’ symptoms of depression. We’ll give up to 12 patients with TRD, aged 18–75 years, a single dose of the study drug, as a nasal spray. The dose we give will be one that was safe and tolerated by healthy volunteers in another study.
Patients will take up to 20 weeks to finish the study. They’ll have a screening visit during the 8 weeks before the study. In the two weeks before receiving the dose, participants will have at least 3 psychedelic preparation visits with an experienced psychedelic researcher. After the dosing visit, patients will have up to 3 integration visits and up to 5 follow-up visits.
A pharmaceutical company (Beckley Psytech Limited) is funding the study.
The study will take place at 2 centres in the UK.
REC name
Wales REC 2
REC reference
22/WA/0215
Date of REC Opinion
8 Sep 2022
REC opinion
Further Information Favourable Opinion