NCT05870540

BPL-003 Efficacy and Safety in Treatment Resistant Depression

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Beckley Psytech Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 study randomized, quadruple masked, multi-center study , with a Open Label Extension, designed to investigate the efficacy and safety of BPL-003 combined with psychological support in patients with treatment resistant depression (TRD).

Detailed description

Approximately 200 eligible participants will receive a single dose of either low, medium, or high doses of BPL-003, given intranasally, with 8 weeks of follow up assessments. Following this participants may receive a second dose of either monophasic or biphasic dose of BPL-003, given intranasally, with another 8 weeks of follow up assessments. Psychological support will be given before, during and after each dosing.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	BPL-003	A single dose administered intranasally
DRUG	BPL-003	A single dose administered intranasally (administered as 2 nasal sprays minutes apart)

Timeline

• Start date: 2023-09-14
• Primary completion: 2025-03-28
• Completion: 2025-07-03
• First posted: 2023-05-23
• Last updated: 2025-07-18

Locations

42 sites across 6 countries: United States, Australia, Germany, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study