Recruiting
Phase 3

LPCN 1154A

Sponsor:

Lipocine Inc.

Code:

NCT07822321

Conditions

Depression, Postpartum

Postpartum Depression (PPD)

Post-partum Depression

Postnatal Depression

Post-Natal Depression

Eligibility Criteria

Sex: Female

Age: 15 - 45

Healthy Volunteers: Not accepted

Interventions

LPCN 1154A

Placebo

Study Details

Brief 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

Conditions

Depression, Postpartum

Postpartum Depression (PPD)

Post-partum Depression

Postnatal Depression

Post-Natal Depression

Study ID

NCT07822321

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15 - 45

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LPCN 1154A Tablets

LPCN 1154A Tablets

placebo comparator: Placebo Tablets

Placebo Tablets

Interventions

LPCN 1154A

Oral LPCN 1154A tablets for 48 hours

Placebo

Oral Placebo Tablets for 48 hours

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Vice President of Clinical Development

801-519-4363siteinquiry@lipocine.com

Locations

Lipocine Investigational Site

Recruiting

Tucson, Arizona, United States, 85715

Lipocine Investigational Site

Recruiting

Canoga Park, California, United States, 91304

Lipocine Investigational Site

Recruiting

Walnut Creek, California, United States, 94596

Lipocine Investigational Site

Recruiting

Aurora, Colorado, United States, 80045

Lipocine Investigational Site

Recruiting

Decatur, Georgia, United States, 30030

Lipocine Investigational Site

Recruiting

Idaho Falls, Idaho, United States, 83402

Lipocine Investigational Site

Recruiting

Chicago, Illinois, United States, 60641

Lipocine Investigational Site

Recruiting

New Orleans, Louisiana, United States, 70115

Lipocine Investigational Site

Recruiting

Las Vegas, Nevada, United States, 89119

Lipocine Investigational Site

Recruiting

Princeton, New Jersey, United States, 08540

Lipocine Investigational Site

Recruiting

Manhattan, New York, United States, 10036

Lipocine Investigational Site

Recruiting

Chapel Hill, North Carolina, United States, 27514

Lipocine Investigational Site

Recruiting

Plano, Texas, United States, 75093

Lipocine Investigational Site

Recruiting

Richardson, Texas, United States, 75080

Lipocine Investigational Site

Recruiting

Clinton, Utah, United States, 84105

Lipocine Investigational Site

Recruiting

Orem, Utah, United States, 84058

More Information

Sponsor

Lipocine Inc.

Last update posted

Sep 16, 2026

Last verified

Sep, 2026

Keywords

  • Postpartum Depression
  • PPD
  • Depression
  • LPCN 1154A
  • brexanolone
  • neuroactive steriod
  • GABAA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Lipocine Inc. on 2026-09-16.