A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD

Phase 3

Not yet recruiting

• Conditions: Depression, Postpartum; Depression, Post-Partum; Postnatal Depression; Postpartum Depression (PPD); Post-Natal Depression; Peripartum Depression
• Interventions: Drug: LPCN 1154A; Drug: Placebo

• Registration Number: NCT06979544
• Lead Sponsor: Lipocine Inc.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Study First Posted: 2025-05-20
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Study Start: 2025-06
• Primary Completion: 2026-04
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LPCN 1154A Tablets	LPCN 1154A	LPCN 1154A
Placebo Tablets	Placebo	Placebo Tablets

Primary Outcome Measures

Name	Time	Method
Change from baseline in HAM-D17 total score compared to placebo	Baseline to Hour 60	The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) contains 17 individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia (initial, middle, and late), work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, sexual interest, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.

Secondary Outcome Measures

Name	Time	Method
Incidence, severity, and causality of AEs and SAEs	upto Day 30	Adverse events (AEs) and Serious Adverse Events (SAEs)
Change from baseline in HAM-D17 total score	Baseline at Hours 12, and 36, Day 7 and Day 30	The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) evaluates mood, suicide, work and interests, retardation, agitation, gastrointestinal symptoms, somatic symptoms, hypochondriasis, body weight and insight The total score ranges from 0 to 52, with higher scores indicating more severe depression.
HAM-D17 response	Baseline to Hours 12, and 36, 60, Day 7 and Day 30	Defined as having a 50% or greater reduction from baseline in HAM-D17 total score. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
HAM-D17 remission	Hours 12, and 36, 60, Day 7 and Day 30	Defined as having a HAM-D17 total score ≤7. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Patient Global Impression - Change (PGI-C) scale positive response	Hours 12, and 36, 60, Day 7 and Day 30	The PGI-C scale is a 7-point scale that ranges from "1-very much better" to "7-very much worse" that allows participants to self- report their perception of improvement or decline of overall symptoms since starting treatment.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score	Baseline to Hour 60 and Day 30	The MADRS is a 10-item assessment that evaluates mood/thoughts, sleep, appetite, tension, concentration The total score ranges from 0 to 60, with higher scores indicating more severe depression.
Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score	Baseline to Hours 12, 36, 60 Day 7 and Day 30	The HAM-A is a 14-item assessment that evaluates mood, tension, fear, memory/concentration, sleep, and physical symptoms affecting somatic, sensory, respiratory, cardiovascular, gastrointestinal, genitourinary, and autoimmune systems as it relates to anxiety. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety.

Trial Locations

Locations (10)

Advance Research Center; 🇺🇸 Anahiem, California, United States

Alliance Research Institute; 🇺🇸 Canoga Park, California, United States

Excell Research, Inc.; 🇺🇸 Oceanside, California, United States

Populace Research; 🇺🇸 Provo, Utah, United States

Meridian International Research; 🇺🇸 Miami Gardens, Florida, United States

Pillar Clinical Research; 🇺🇸 Chicago, Illinois, United States

MedOne Clinical Research, LLC; 🇺🇸 Miami, Florida, United States

CenExel Research Center; 🇺🇸 Decatur, Georgia, United States

Clinical Research Center of Florida; 🇺🇸 Pompano Beach, Florida, United States

Maximos OB/GYN; 🇺🇸 League City, Texas, United States