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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 belowSelect...
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
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 moreSecondary 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 moreAwards & 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
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.
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Who is running the clinical trial?
Brii Biosciences LimitedLead Sponsor
13 Previous Clinical Trials
7,801 Total Patients Enrolled
1 Trials studying Postpartum Depression
41 Patients Enrolled for Postpartum Depression