Status:
RECRUITING
A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD
Lead Sponsor:
Lipocine Inc.
Conditions:
Depression, Postpartum
Depression, Post-Partum
Eligibility:
FEMALE
15-45 years
Phase:
PHASE3
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 symp...
Eligibility Criteria
Inclusion
- Key
- Are female between 15 and 45 years of age, inclusive;
- Have had a depressive episode that began no earlier than third trimester and later than the first 4 week following delivery
- Are \< 12 months postpartum at Screening
- Hamilton Depression Rating Scale (HAM-D) 17-item score indicative of severe depression
- Key
Exclusion
- Have a history of bipolar disorder, schizophrenia or schizoaffective disorder
- Are currently experiencing active psychosis per Investigator assessment
- Have a history of suicidal behavior within 1 year
- Have a history of seizure within 6 months of Screening
Key Trial Info
Start Date :
June 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06979544
Start Date
June 16 2025
End Date
May 1 2026
Last Update
September 12 2025
Active Locations (18)
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1
Advanced Research Center
Anahiem, California, United States, 92805
2
Alliance Research Institute
Canoga Park, California, United States, 91304
3
MedOne Clinical Research, LLC
Miami, Florida, United States, 33145
4
D&H National Research Centers
Miami, Florida, United States, 33155