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BPL-003 Efficacy and Safety in Treatment Resistant Depression

NCT05870540 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-07-18

No results posted yet for this study

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).

Conditions

Interventions

DRUG

BPL-003

A single dose administered intranasally

DRUG

BPL-003

A single dose administered intranasally (administered as 2 nasal sprays minutes apart)

Sponsors & Collaborators

  • Beckley Psytech Limited

    lead INDUSTRY

Principal Investigators

  • VP & Head of Clinical Development · Beckley Psytech Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-14
Primary Completion
2025-03-28
Completion
2025-07-03
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Germany
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05870540 on ClinicalTrials.gov