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

Brii Biosciences

Status and phase: Completed; Phase 2

Conditions: Severe Postpartum Depression

Treatments: Drug: Depo Medrol; Drug: BRII-296

Study type: Interventional

Funder types: Industry

Identifiers

NCT06057012

BRII-296-002

Details and patient eligibility

About

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).

Enrollment: 11 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 1 patient group

BRII-296 + Depo Medrol

Experimental group

Description:

Participants will receive BRII-296 600 milligram (mg) and Depo Medrol (80 milligram per milliliter \[mg/mL\]) on Day 1 as a combination therapy.

Treatment:

Drug: BRII-296

Drug: Depo Medrol