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First received: September 21, 2023

Clinical Trial: A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD)

Study Status: Completed

Recruit Status: RECRUITING

Condition: Severe Postpartum Depression

Study Type: INTERVENTIONAL


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)

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).

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