Clinical trial NCT06979544: A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD
Official title: A Randomized, Blinded, Placebo-Controlled Study to Evaluate the Saftey and Efficacy of Oral LPCN 1154A in Women With Postpartum Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Depression, Postpartum
Depression, Post-Partum
Postpartum Depression (PPD)
Post-Natal Depression
Peripartum Depression
Postnatal Depression
Lead sponsor: Lipocine Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 80
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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
* If LPCN 1154A reduces anxiety symptoms in subjects with severe PPD


Eligibility criteria: Key Inclusion Criteria:

* 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 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 within 1 year
* Have a history of seizure within 6 months of Screening

Primary outcomes:
measure: Change from baseline in HAM-D17 total score compared to placebo
timeFrame: Baseline to Hour 60
Secondary outcomes:
measure: Incidence, severity, and causality of AEs and SAEs
timeFrame: upto Day 30
measure: Change from baseline in HAM-D17 total score
timeFrame: Baseline at Hours 12, and 36, Day 7 and Day 30
measure: HAM-D17 response
timeFrame: Baseline to Hours 12, and 36, 60, Day 7 and Day 30
measure: HAM-D17 remission
timeFrame: Hours 12, and 36, 60, Day 7 and Day 30
measure: Patient Global Impression - Change (PGI-C) scale positive response
timeFrame: Hours 12, and 36, 60, Day 7 and Day 30
measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
timeFrame: Baseline to Hour 60 and Day 30
measure: Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score
timeFrame: Baseline to Hours 12, 36, 60 Day 7 and Day 30
Other outcomes:
Locations:
city: Anahiem
country: United States
facility: Advance Research Center
state: California
city: Canoga Park
country: United States
facility: Alliance Research Institute
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: Miami Gardens
country: United States
facility: Meridian International Research
state: Florida
city: Miami
country: United States
facility: MedOne Clinical Research, LLC
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Decatur
country: United States
facility: CenExel Research Center
state: Georgia
city: Chicago
country: United States
facility: Pillar Clinical Research
state: Illinois
city: League City
country: United States
facility: Maximos OB/GYN
state: Texas
city: Provo
country: United States
facility: Populace Research
state: Utah
Study officials:
References: