ProjectBPL-003 – A Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003, with…

Basic data

Acronym:

BPL-003

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

Duration:

09/10/2023 to 30/09/2025

Abstract / short description:

This is a Phase 2b study consisting of a CORE and an optional Open label extension (OLE). The CORE is a randomized, quadruple masked (participant, therapists, investigator, and MADRS rater), multi-center study designed to investigate the efficacy and safety of BPL-003 combined with psychological support in patients with TRD not currently taking antidepressants. The OLE is designed to investigate the safety and efficacy during and after a second dose of BPL-003 combined with psychological support in patients with TRD not currently taking antidepressants.

Keywords:

depression

Depression

psychiatry

Psychiatrie

international studies

Internationale Studien

psychotherapy research

Psychotherapieforschung

Psycheldelica