clinical trial · NCT06057012
A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD)
Severe Postpartum DepressionBRII-296Depo Medrol
brief 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).
started
Sep 29, 2023
primary completion
Mar 13, 2024
completion
Mar 13, 2024
last updated
Jan 27, 2025
official title
A Phase 2a, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Descriptive Efficacy of BRII-296 in Adults With Severe Postpartum Depression (PPD)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol