BPL-003 Efficacy and Safety in Treatment Resistant Depression
This quadruple-masked, randomised, multi-centre Phase II study (n=225) investigates the efficacy and safety of a single intranasal dose of BPL-003, combined with psychological support, in patients with treatment-resistant depression (TRD).
Details
Randomised, quadruple-masked multi-centre Phase II study in treatment‑resistant depression assessing single intranasal doses of BPL‑003 (low/medium/high) with psychological support and 8‑week follow-up.
Approximately 196 participants are recorded as actual enrolment in the registry fragment; participants receive one dose and may receive a second monophasic or biphasic intranasal dose in an open‑label extension, with further 8‑week follow-up.
Psychological support is provided before, during and after dosing; outcomes include depression severity (HDRS), CGI-S and safety assessments including ECG and medical monitoring.