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
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.
REC name
Wales REC 2
REC reference
23/WA/0070
Date of REC Opinion
27 Sep 2023
REC opinion
Further Information Favourable Opinion