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Brexanolone Lifting Outcomes Of Moms

RecruitingPhase 3Ages 15 Years - 45 YearsFemaleLipocine Inc.
NCT07822321 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • LPCN 1154A
  • Placebo
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Where

16 sites
Lipocine Investigational Site
Tucson, United States
Lipocine Investigational Site
Canoga Park, United States
Lipocine Investigational Site
Walnut Creek, United States
Lipocine Investigational Site
Aurora, United States
Lipocine Investigational Site
Decatur, United States
Lipocine Investigational Site
Idaho Falls, United States
Lipocine Investigational Site
Chicago, United States
Lipocine Investigational Site
New Orleans, United States

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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