Evaluation of BPL-003 in patients with major depressive disorder
Research type
Research Study
Full title
An Open-Label Study to Evaluate BPL-003 as Adjunctive Therapy in Patients with Major Depressive Disorder and Non or Partial Response to Selective Serotonin Reuptake Inhibitor (SSRI) Treatment
IRAS ID
1006208
Contact name
Kiara Batten
Contact email
Sponsor organisation
Beckley Psytech Ltd
Eudract number
2022-002641-18
Research summary
BPL-003 is a psychedelic substance (occurs naturally in some plants and animals) being developed as a therapy for major depressive disorder (MDD). This study will determine side effects and potential benefits as well as psychedelic effects of the study drug in patients with MDD who have had either no response or partial response to serotonin reuptake inhibitors (SSRI). The dose of BPL-003 will be determined from the Phase 1 study in healthy volunteers (BPL-003-103). The dose selected will be safe and well tolerated by the healthy volunteers. Patients will receive a single dose, via a nasal spray.
BPL-003 will be given to 12 patients, men and women, aged 18-75 years, diagnosed with MDD but who are otherwise healthy. Participants will participate in a minimum of 3 preparatory psychological support sessions prior to BPL-003 study treatment. Study treatment will be administered according to established safety practices for psychedelic research. An optional one-to-one guided interview with independent trained researchers to discuss their psychedelic experience will be performed after the patients return to their usual state of consciousness after dosing. A minimum of 3 integration sessions will occur over the following 2 weeks. Participants will be followed–up for 12 weeks post dose which includes 5 visits. Total patient participation from screening to the final visit is approximately 16 weeks.
Safety will be assessed by blood samples, electrocardiograms, cardiac telemetry and vital signs. Suicide risk assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) and adverse events and concomitant medications collected throughout. Examination of the nose will be performed before and after dosing.
Efficacy will be assessed using rating scales and questionnaires validated for research in this area to assess symptoms of MDD and the patient's impression and experience of the treatment on their condition
Up to 2 psychiatric clinics will conduct the study.REC name
Wales REC 2
REC reference
22/WA/0219
Date of REC Opinion
7 Sep 2022
REC opinion
Further Information Favourable Opinion