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Taking people in United StatesPhase 3

Brexanolone Lifting Outcomes Of Moms

Key facts

Who runs it
Lipocine Inc.
Where
Aurora, Canoga Park, Chapel Hill, Chicago, Clinton, Decatur, Idaho Falls, Las Vegas, Manhattan, New Orleans, Orem, Plano, Princeton, Richardson, Tucson, and Walnut Creek, United StatesSee the 16 sites
Trial code
Status
Recruiting
Phase
Phase 3
People taking part
120 people, planned
Started
Sept 2026
Expected to end
Sept 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • LPCN 1154A
  • Placebo
Record updated
16 September 2026

Who can take part

Age
15 years to 45 years
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

  • Have a history of bipolar disorder, schizophrenia or schizoaffective disorder
  • Have a history of suicidal behavior associated with the current depressive episode
  • Have a history of seizure within six months of Screening
  • Are currently experiencing active psychosis per Investigator assessment

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 15 and 45 years old?

Where in United States

  • Aurora, ColoradoHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people
  • Canoga Park, CaliforniaHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people
  • Chapel Hill, North CarolinaHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people
  • Chicago, IllinoisHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people
  • Clinton, UtahHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people
  • Decatur, GeorgiaHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people
  • Idaho Falls, IdahoHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people
  • Las Vegas, NevadaHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people
  • Manhattan, New YorkHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people
  • New Orleans, LouisianaHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people
  • Orem, UtahHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people
  • Plano, TexasHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people
  • Princeton, New JerseyHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people
  • Richardson, TexasHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people
  • Tucson, ArizonaHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people
  • Walnut Creek, CaliforniaHospital not named in the registryContact: Vice President of Clinical DevelopmentTaking people

About the trial

What the trial wants to find out

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:

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* If LPCN 1154A reduces depressive symptoms in subjects with severe PPD * How well LPCN 1154A is tolerated and what side effects it may cause

The 2 groups in the trial

  • LPCN 1154A TabletsTreatment being tested

    Treatment: LPCN 1154A

  • Placebo TabletsPlacebo, for comparison

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized, Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Oral LPCN 1154A in Women With Postpartum Depression
Fit questions
Built from NCT07822321, who can take part
Record updated
16 September 2026