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An Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression

Treatment Resistant Depression Clinical Trial

Official title:
An Open-Label, Phase 2a, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression

Clinical Trial Summary

An open-label, multi-centre, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamics of a single intranasal dose of BPL-003 combined with psychological support, in patients with treatment resistant depression when administered as monotherapy or as adjunctive therapy with defined SSRIs (citalopram, escitalopram, or sertraline).

Clinical Trial Description

Up to 52 patients, across 2 parallel arms (Arms A and Arms B) will receive one of two single doses of BPL-003, given intranasally, with 12 weeks of follow-up assessments. Psychological support will be given before, during and after dosing. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05660642
Study type Interventional
Source Beckley Psytech Limited
Contact Beckley Psytech Ltd
Phone +44 (0)1865 987633
Email Medinfo@beckleypsytech.com
Status Recruiting
Phase Phase 2
Start date February 10, 2023
Completion date November 2024
View Details
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