An open-label, multi-centre, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamics of one and two doses of intranasal 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, sertraline or fluoxetine).
Diagnosed with Major Depressive Disorder.
Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments in the past 5 years prior to screening, at least one of which is during the current episode.
Montgomery-Asberg Depression Rating Scale score ≥24 at Screening.
Clinical Global Impression - Severity ≥4 at Screening.
Current or history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder.
Current personality disorders.
First-degree family history of schizophrenia, bipolar disorder, delusional disorder, personality disorders or schizoaffective disorder.
Current alcohol or substance use disorder (other than caffeine or nicotine).