Evaluate the Efficacy & Safety of Intranasal BPL-003 in Patients with Treatment Resistant Depression
Research type
Research Study
Full title
A Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003, with Open Label Extension, in Patients with Treatment Resistant Depression
IRAS ID
1007266
Contact name
Ruth Bateson
Contact email
Sponsor organisation
Beckley Psytech Ltd.
Eudract number
2022-003743-10
Clinicaltrials.gov Identifier
Research summary
Research Summary
There is an unmet medical need for effective medications to treat patients with Treatment Resistant Depression (TRD). TRD refers to a condition in which patients with major depressive disorder have tried at least 2 different antidepressant therapies without adequate response. The main purpose of this research is to study the effectiveness, safety and tolerability of a psychedelic compound, called BPL-003 given intranasally accompanied by psychological support. BPL-003 is similar to a psychedelic substance that occurs naturally in many plants and some animals. Psychedelic substances act on the brain causing temporary changes to how the brain interprets information/thoughts, feelings and emotions. The study will be conducted in approximately 7 countries at around 40 clinics or hospitals and is expected to have 225 study participants. The research study lasts for around 25 weeks. Three different dosages of the study drug (very low, medium, high) will be tested. The first part of the study is “blinded”, so no one knows the treatment assignment and which of the 3 doses will be given. The second part is optional, and the treatment dose (high dose) is known to the study doctor, therapist, other study team staff and patient. Both parts include assessments like laboratory (blood) tests, electrocardiogram (heart rate test), clinical and psychiatric evaluations and the completion of patient reported outcome questionnaires etc. Both parts also include psychotherapist support sessions before, during and after dosing with BPL-003.
Summary of Results
A STUDY TO TEST DIFFERENT DOSES OF BPL-003 IN PEOPLE WITH TREATMENT-RESISTANT DEPRESSION
WHY WAS THIS STUDY DONE?
BPL-003 is a psychoactive experimental medicine, meaning it affects thoughts, feelings and senses. Treatment-resistant depression is depression that doesn't improve even after trying different antidepressants. This study aimed to find out if BPL-003 could improve depression symptoms in people who have not benefited from antidepressants, and to study its safety.
HOW WAS THIS STUDY DONE?
The study was blinded: participants, doctors and researchers did not know which dose a participant received, decided randomly by computer. BPL-003 was given as a single nasal-spray dose:Low dose (0.3 mg) - expected to have little or no effect, used as a comparison
Medium dose (8 mg)
High dose (12 mg)
Participants received support from the research team before, during and after dosing, and were monitored by study doctors. After dosing, participants completed regular questionnaires and interviews for 2 months and attended follow-up visits. Some participants then chose to continue into an extension part of the study (see "What happened after this study").
WHERE AND WHEN
The study ran from September 2023 to July 2025 across 6 countries (100 participants from the EU):
UK: 17; USA: 55; Spain: 13; Germany: 38; Poland: 49; Australia: 21.
WHO TOOK PART
Eligible participants were aged 18-75, had depression worse than "mild," had treatment-resistant depression, and were not taking antidepressants or were willing to stop before joining.
193 participants received treatment: 114 women (59%), 79 men (41%). Ages ranged 19-73 (average 41). Only a small number left the study early.
Ethnicity: White 89%, Asian 6%, Black/African American 5%, multiple race <1%.
WHAT WERE THE RESULTS?
Participants who received any dose had improved depression symptoms (measured on a standard rating scale). Around 1 month after dosing, symptoms were lower by:
Low dose: 6 points; Medium dose: 12 points; High dose: 11 points.
Improvement was greater with the medium/high dose than the low dose, appeared from 2 days after dosing, and lasted at least 2 months.
MEDICAL EVENTS
Medical events (health issues after starting treatment, which may or may not relate to BPL-003) are graded mild (no effect on daily life), moderate (some discomfort) or severe (disrupted daily life):
Low dose: 54/74 (73%) had events - 64% mild, 32% moderate
Medium dose: 35/46 (76%) had events - 76% mild, 37% moderate
High dose: 62/73 (85%) had events - 84% mild, 51% moderate, 1% severe
Most events were mild or moderate. There was 1 severe event (panic attacks, high dose).
Two serious medical events occurred: 1 episode of serious depression (low dose) and 1 episode of severe agitation (medium dose). Both resolved and were judged unlikely to be related to BPL-003. No participants died during the study.
CONCLUSIONS
Participants had improved depression symptoms after a medium or high dose of BPL-003 compared with the low dose, lasting at least 2 months. There were more medical events with the high dose than the medium dose. Researchers concluded the medium dose should be examined further in future studies.
We’d like to thank everyone who took part in this study. You helped us answer questions about BPL-003 and the different ways we could treat depression.
WHAT HAPPENED AFTER THIS STUDY
Some participants chose to continue and received a further high dose of BPL-003 (as one or two sprays), to learn more about safety and repeat dosing. Similar medical events occurred, including one serious event related to BPL-003, which resolved.
WHAT HAPPENS NEXT
More clinical studies of BPL-003 are needed to further test its safety and effects in people with treatment-resistant depression.
MORE INFORMATION
Full study title: A quadruple masked, dose-finding study to evaluate the efficacy and safety of intranasal BPL-003, with open label extension, in patients with treatment-resistant depression (protocol BPL-003-201).
EU CT number 2022-003743-10 - https://euclinicaltrials.eu/search-for-clinical-trials
(a more graphical version of this summary can be found on this website)
NCT number NCT05870540 - www.clinicaltrials.gov
Funded by Beckley Psytech Ltd. (an AtaiBeckley company). Contact: https://www.ataibeckley.com/contact
IMPORTANT NOTE
This lay summary is provided as part of Beckley Psytech Ltd.'s (an AtaiBeckley company) commitment to publicly share clinical study results. It may include uses, formulations or treatment plans not approved in your country. Do not change your treatment based on these results - always consult your doctor.REC name
Wales REC 2
REC reference
23/WA/0070
Date of REC Opinion
27 Sep 2023
REC opinion
Further Information Favourable Opinion