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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-29

Study Completion Date

2024-03-13

Brief Summary

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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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Detailed Description

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Conditions

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Severe Postpartum Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BRII-296 + Depo Medrol

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

Group Type EXPERIMENTAL

BRII-296

Intervention Type DRUG

BRII-296 will be given via intramuscular injection.

Depo Medrol

Intervention Type DRUG

Depo Medrol will be given via intramuscular injection.

Interventions

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BRII-296

BRII-296 will be given via intramuscular injection.

Intervention Type DRUG

Depo Medrol

Depo Medrol will be given via intramuscular injection.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No