Clinical trial for Depression, Postpartum
Official title Brexanolone Lifting Outcomes Of Moms
ClinicalTrials.gov ID: NCT07822321
What this study is testing
What is LPCN 1154A?
LPCN 1154A is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for depression, postpartum.
Also referred to as Brexanolone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research study is to test the study drug, LPCN 1154A, as a possible treatment for postpartum depression (PPD). The trial aims to determine: If LPCN 1154A reduces depressive symptoms in subjects with severe PPD How well LPCN 1154A is tolerated and what side effects it may cause
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 45, women only
You may be able to join if
- Are female between 15 and 45 years of age, inclusive;
- Have had a depressive episode that began no earlier than second trimester and no later than the first 4 weeks following delivery
- Are \< 18 months postpartum at Screening
- Hamilton Depression Rating Scale (HAM-D) 17-item score indicative of severe depression Key
You likely can't join if
- Have a history of bipolar disorder, schizophrenia or schizoaffective disorder
- Are currently experiencing active psychosis per Investigator assessment
- Have a history of suicidal behavior associated with the current depressive episode
- Have a history of seizure within six months of Screening
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Canoga Park, California, United States
- Walnut Creek, California, United States
- Aurora, Colorado, United States
- Decatur, Georgia, United States
- Idaho Falls, Idaho, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- Las Vegas, Nevada, United States
- Princeton, New Jersey, United States
- Manhattan, New York, United States
- Chapel Hill, North Carolina, United States
- Plano, Texas, United States
- Richardson, Texas, United States
- Clinton, Utah, United States
- Orem, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 15 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Canoga Park, California, United States; Walnut Creek, California, United States; Aurora, Colorado, United States; Decatur, Georgia, United States; Idaho Falls, Idaho, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.