Brexanolone Lifting Outcomes Of Moms

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Lipocine Inc.
Study ID
NCT07822321
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Depression, Postpartum
  • Peripartum Depression
  • Post-Natal Depression
  • Post-partum Depression
  • Postnatal Depression
  • Postpartum Depression (PPD)

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • LPCN 1154A — DRUG
    Oral LPCN 1154A tablets for 48 hours
  • Placebo — DRUG
    Oral Placebo Tablets for 48 hours

Study Details

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

Key Dates

First listed
Sep 16, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Aug 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LPCN 1154A Tablets
    LPCN 1154A Tablets
  • Placebo Comparator: Placebo Tablets
    Placebo Tablets

Primary Outcome Measure

Change from baseline in HAM-D17 total score compared to placebo [ Time Frame: Baseline to Hour 60 ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Lipocine Investigational SiteTucsonArizona85715-
Lipocine Investigational SiteCanoga ParkCalifornia91304-
Lipocine Investigational SiteWalnut CreekCalifornia94596-
Lipocine Investigational SiteAuroraColorado80045-
Lipocine Investigational SiteDecaturGeorgia30030-
Lipocine Investigational SiteIdaho FallsIdaho83402-
Lipocine Investigational SiteChicagoIllinois60641-
Lipocine Investigational SiteNew OrleansLouisiana70115-
Lipocine Investigational SiteLas VegasNevada89119-
Lipocine Investigational SitePrincetonNew Jersey08540-
Lipocine Investigational SiteManhattanNew York10036-
Lipocine Investigational SiteChapel HillNorth Carolina27514-
Lipocine Investigational SitePlanoTexas75093-
Lipocine Investigational SiteRichardsonTexas75080-
Lipocine Investigational SiteClintonUtah84105-
Lipocine Investigational SiteOremUtah84058-

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