Phase 2a Open-Label Study of Intranasal BPL-003 for Safety and Effects in Adults With Treatment Resistant Depression

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacodynamics of intranasal BPL-003 in patients with treatment resistant depression. This Phase 2a open-label study includes patients who have not responded to at least two prior antidepressant treatments, focusing on both monotherapy and adjunctive therapy with selected SSRIs. Psychological support is provided throughout the study to assist participants during treatment. The study is divided into two parts. In Part 1, up to 32 patients receive a single dose of BPL-003 intranasally across two dose groups, followed by 12 weeks of follow-up. In Part 2, up to 40 patients receive two doses of BPL-003, also administered intranasally, with 10 weeks of follow-up. Psychological support is given before, during, and after dosing in both parts to support participants. Participants will undergo assessments including physical examinations, vital signs, electrocardiograms, laboratory tests, and depression rating scales throughout the study. Researchers will monitor safety and tolerability from baseline to up to 12 weeks post dose. The study aims to assess how patients respond to one or two doses of BPL-003 and track any side effects or changes in their condition during the follow-up period.

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