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).
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.
Single intranasal low dose of BPL-003 (active placebo comparator).
BPL-003 low dose (exact dose not specified in source).
Single intranasal medium dose of BPL-003.
BPL-003 medium dose (exact dose not specified in source).
Single intranasal high dose of BPL-003.
BPL-003 high dose (exact dose not specified in source).
Single monophasic intranasal BPL-003 (possible second-dose OLE).
Monophasic BPL-003 formulation; second dose may be given in OLE.
Biphasic intranasal BPL-003 administered as two sprays minutes apart.
Biphasic: two nasal sprays minutes apart; used in OLE/second-dose schedule.