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RecruitingPhase 3

Brexanolone Lifting Outcomes Of Moms

A Randomized, Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Oral LPCN 1154A in Women With Postpartum Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
15 Years to 45 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests LPCN 1154A as a possible treatment for severe postpartum depression, or depression after childbirth. It is for females ages 15 to 45 who gave birth less than 18 months ago. The study will check whether the drug eases depression symptoms and what side effects it may cause.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are female and 15 to 45 years old.
  • Have a period of depression that began between the second trimester of pregnancy and the first 4 weeks after childbirth.
  • Gave birth less than 18 months before the screening visit.
  • Have severe depression based on the 17-question Hamilton Depression Rating Scale.

Who can't join

  • Have a history of bipolar disorder, which causes major mood swings, or schizophrenia or schizoaffective disorder, which can affect thoughts and sense of reality.
  • Currently have psychosis, or trouble knowing what is real, based on the study doctor's assessment.
  • Have had suicidal behavior during the current period of depression.
  • Have had a seizure within 6 months before the screening visit.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study sites (16)

AZ

CA

CO

GA

ID

IL

LA

NC

NJ

NV

NY

TX

UT