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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at days 2, 3, 4, 8, 15, 30, and 45
Awards & highlights

Study Summary

This trial evaluates the safety and tolerability of a drug given by injection to measure side effects, vital signs, sleepiness, and suicidal thoughts.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Glasgow Coma Scale (GCS) Score
Change From Baseline in Stanford Sleepiness Scale (SSS) Score
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters
+12 more
Secondary outcome measures
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

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

Find a Location

Who is running the clinical trial?

Brii Biosciences LimitedLead Sponsor
11 Previous Clinical Trials
7,471 Total Patients Enrolled
1 Trials studying Postpartum Depression
41 Patients Enrolled for Postpartum Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this research restricted to adults or can minors participate?

"In accordance with the trial's prerequisites, only individuals aged 18-45 are permitted to participate."

Answered by AI

Am I qualified to enroll in this research experiment?

"Eligibility criteria for this study are postpartum depression and an age between 18 to 45. 24 individuals may qualify if they meet the requirements."

Answered by AI

Has the FDA sanctioned BRII-296 600 mg for medicinal use?

"Per our assessment, BRII-296 600 mg's safety is rated 2 out of 3 due to Phase 2 clinical trial data indicating it meets established safety requirements but has yet to prove efficacy."

Answered by AI

Are there still opportunities for patients to join this clinical trial?

"Clinicaltrials.gov indicates that this trial, which was originally listed on September 1st 2023, is actively seeking enrollees. The records were last revised on September 21st of the same year."

Answered by AI

What is the target recruitment size for this research project?

"Affirmative, the clinicaltrial.gov portal confirms that this investigation is currently recruiting candidates. First established on September 1st 2023 and last edited on the 21st of September 2023, it aims to enroll 24 individuals at a single site."

Answered by AI

What key goals is this research endeavor seeking to achieve?

"According to the clinical trial sponsor, Brii Biosciences Limited, the primary outcome being evaluated will be Adverse Events (AEs) determined over a 45-day period. Secondary outcomes assessed include HAM-D Response and Remission scores as well as CGI-I Response ratings within this same time frame. The HAM-D is a 17 item scale that measures depression severity on a range of 0 - 52; higher score indicating more severe symptoms. Meanwhile, CGI-I employes a 7 point Likert scale in order to gauge overall improvement from treatment with response choices ranging from "very much improved" to "very much worse"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD)
2023. "A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06057012.
~7 spots leftby Apr 2025
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