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BRII-296 for Postpartum Depression
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
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."
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."
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."
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."
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."
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"
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