A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD)
Status:
Completed
Trial end date:
2024-03-13
Target enrollment:
Participant gender:
Summary
The primary purpose of this study is to evaluate the safety and tolerability of BRII-296
administered by 2 intramuscular injections, administered with Depo Medrol as assessed by the
incidence of adverse events, changes from baseline in vital signs, pulse oximetry, clinical
laboratory evaluations, electrocardiograms (ECGs), Stanford Sleepiness Scale (SSS), Glasgow
Coma Scale (GCS) in conjunction with clinical assessment, and suicidal ideation using the
Columbia Suicide Severity Rating Scale (C-SSRS).