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

Completed · Phase 2

Conditions studied: Severe Postpartum Depression

In brief

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).

Key facts

Study ID

NCT06057012

Run by

Brii Biosciences Limited

People needed

11

Starts

2023-09-29

Expected to finish

2024-03-13

Last updated by the study team

2025-01-27

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant either must have ceased lactating at screening or is still lactating actively breastfeeding at screening , must agree temporarily cease giving breast milk to her infant(s)
• Participant has had a Major Depressive Episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
• Participant was <12 months postpartum
• Participant is amenable to intramuscular administration of investigational product on Day 1 and remaining inpatient until at least Day 4

You may not qualify if…

• Active psychosis
• Attempted suicide associated with current episode of postpartum depression
• Medical history of seizures
• Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder

Where it is running

• Cenexel CNR — Sherman Oaks, California, United States
• CenExel CNS-Torrance — Torrance, California, United States
• Clinical Research Center of Florida — Boynton Beach, Florida, United States
• Aventura Clinical Research, LLC — Davie, Florida, United States
• South Florida Research Phase I-IV Inc — Miami Springs, Florida, United States
• Synexus Clinical Research US, Inc. — Atlanta, Georgia, United States
• Cenexel ACMR Atlanta Center for Medical Research — Atlanta, Georgia, United States
• iResearch Atlanta, LLC — Decatur, Georgia, United States
• Research Carolina Elite — Denver, North Carolina, United States
• North Texas Clinical Trials — Fort Worth, Texas, United States
• Maximos OB/GYN — League City, Texas, United States

Full record on ClinicalTrials.gov

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