What side effects are associated with this type of intervention?

Common treatments for Postpartum Depression (PPD) include SSRIs, SNRIs, and other antidepressants. Known side effects of these treatments can include nausea, headache, dizziness, dry mouth, insomnia, and sexual dysfunction. Specific to SNRIs like duloxetine and venlafaxine, there may be an increased risk of preterm birth and postpartum hemorrhage. Additionally, poor neonatal adaptation syndrome has been observed with late pregnancy use of some antidepressants. The safety profile of BRII-296, which is being studied for PPD, includes monitoring for adverse events, changes in vital signs, and suicidal ideation.

What prior FDA approvals exist?

The FDA has approved brexanolone (Zulresso) for the treatment of postpartum depression. Brexanolone is a neuroactive steroid that acts as a positive allosteric modulator of GABA-A receptors, providing rapid relief of depressive symptoms. Another drug, zuranolone, is under investigation and works similarly. These treatments focus on modulating neurotransmitter systems to alleviate symptoms. BRII-296, being studied for its safety and tolerability, involves intramuscular injections and is assessed for adverse events, vital signs, and other clinical parameters, indicating a focus on both efficacy and safety in its pharmacological profile.

What other types of research exist?

Promising novel alternatives to BRII-296 for postpartum depression (PPD) treatment include brexanolone and zuranolone. Brexanolone, an intravenous formulation of allopregnanolone, has been approved by the FDA and has shown rapid and sustained antidepressant effects specifically for PPD. Zuranolone, an oral neuroactive steroid, is currently under investigation and has demonstrated potential for rapid symptom relief with a favorable safety profile in clinical trials. Both medications target the GABA-A receptor, which is believed to play a role in the pathophysiology of PPD.

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Monoclonal Antibodies

BRII-296 for Postpartum Depression

Phase 2

Waitlist Available

Research Sponsored by Brii Biosciences Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is amenable to intramuscular administration of investigational product on Day 1 and remaining inpatient until at least Day 4

Be between 18 and 65 years old

Must not have

Medical history of seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and at days 2, 3, 4, 8, 15, 30, and 45

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if two shots of a drug called BRII-296, given with another medication called Depo Medrol, are safe and well-tolerated in patients. The study will look at side effects and changes in health indicators to ensure the treatment is safe.

Who is the study for?

This trial is for adults within 12 months postpartum suffering from severe depression that started between the third trimester and up to four weeks after delivery. Participants must be willing to stay inpatient until at least Day 4, can receive intramuscular injections, and if breastfeeding, agree to stop temporarily. Those with active psychosis, a history of seizures or bipolar/schizophrenia-related disorders, or suicide attempts linked to their current depressive episode cannot join.

What is being tested?

The study tests BRII-296's safety and tolerability for severe postpartum depression through two intramuscular injections alongside Depo Medrol. It monitors adverse events, vital signs changes, oxygen levels, lab results, heart activity (ECGs), sleepiness (SSS), consciousness level (GCS), and suicidal thoughts using C-SSRS.

What are the potential side effects?

Potential side effects include reactions at the injection site, changes in alertness or consciousness levels as measured by SSS and GCS scales respectively; alterations in heart function seen on ECGs; shifts in laboratory values indicating organ function; plus any other reported discomforts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I agree to get a shot on Day 1 and stay in the hospital until at least Day 4.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at days 2, 3, 4, 8, 15, 30, and 45

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and at days 2, 3, 4, 8, 15, 30, and 45

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at days 2, 3, 4, 8, 15, 30, and 45 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Glasgow Coma Scale (GCS) Score

Change From Baseline in Stanford Sleepiness Scale (SSS) Score

Number of Participants With Adverse Events (AEs) According to Severity

+1 more

Secondary study objectives

Change From Baseline in Clinical Global Impression - Severity (CGI-S) Response

Change From Baseline in HAM-D Bech-6 Subscale Score

Change From Baseline in HAM-D Individual Item Score

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BRII-296 600 mgExperimental Treatment1 Intervention

Participants will receive BRII-296 600 milligram (mg) by intramuscular injection admixed with Depo Medrol (80 milligram per milliliter \[mg/mL\]) on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BRII-296

2023

Completed Phase 2

~20

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Postpartum Depression (PPD) include selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and other antidepressants. SSRIs, such as sertraline and fluoxetine, work by increasing the levels of serotonin in the brain, which helps improve mood and reduce anxiety. SNRIs, like venlafaxine, increase both serotonin and norepinephrine levels, providing a broader range of mood stabilization. The investigational drug BRII-296, administered via intramuscular injections, is being studied for its safety and tolerability, potentially offering a new treatment option with a different administration route. Understanding these mechanisms is crucial for PPD patients as it helps in selecting the most effective treatment with the least side effects, ensuring better management of their condition and overall well-being.