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Clinical Trials in the USA / NCT07822321
Recruiting Phase 3

Brexanolone Lifting Outcomes Of Moms

NCT07822321 · tracked via the Priya Life Science USA tracker
Sponsor
Lipocine Inc
Phase
Phase 3
Started
2026-09
Last updated
2026-09-16

Condition(s) studied

Depression, PostpartumPostpartum Depression (PPD)Post-partum DepressionPostnatal DepressionPost-Natal DepressionPeripartum Depression

Investigational drug(s) / intervention(s)

LPCN 1154APlacebo

LPCN 1154A: Oral LPCN 1154A tablets for 48 hours

Placebo: Oral Placebo Tablets for 48 hours

Study summary

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

Eligibility

Sex
FEMALE
Min age
15 Years
Max age
45 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change from baseline in HAM-D17 total score compared to placebo — Baseline to Hour 60
    The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) contains 17 individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia (initial, middle, and late), work and activities, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, genital symptoms, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.

Trial sites (16)

FacilityCityRegionStatus
Lipocine Investigational Site Tucson Arizona Recruiting
Lipocine Investigational Site Canoga Park California Recruiting
Lipocine Investigational Site Walnut Creek California Recruiting
Lipocine Investigational Site Aurora Colorado Recruiting
Lipocine Investigational Site Decatur Georgia Recruiting
Lipocine Investigational Site Idaho Falls Idaho Recruiting
Lipocine Investigational Site Chicago Illinois Recruiting
Lipocine Investigational Site New Orleans Louisiana Recruiting
Lipocine Investigational Site Las Vegas Nevada Recruiting
Lipocine Investigational Site Princeton New Jersey Recruiting
Lipocine Investigational Site Manhattan New York Recruiting
Lipocine Investigational Site Chapel Hill North Carolina Recruiting
Lipocine Investigational Site Plano Texas Recruiting
Lipocine Investigational Site Richardson Texas Recruiting
Lipocine Investigational Site Clinton Utah Recruiting
Lipocine Investigational Site Orem Utah Recruiting

Other trials for the same condition

SAINT in Postpartum Depression (PPD) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07822321 on ClinicalTrials.gov ↗ ← All trials in the USA