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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified April 2025 by Lipocine Inc.
Sponsor
Lipocine Inc.
Information Provided by (Responsible Party)
Lipocine Inc.
Clinicaltrials.gov Identifier
NCT06979544
Other Study ID Numbers:
LPCN 1154-24-002a
First Submitted
May 12, 2025
First Posted
May 19, 2025
Last Update Posted
February 23, 2026
Last Verified
April 2025

ClinicalTrials.gov processed this data on February 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Depression, PostpartumDepression, Post-PartumPostpartum Depression (PPD)Post-Natal DepressionPeripartum DepressionPostnatal Depression
Drug: LPCN 1154ADrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment90 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Randomized, Blinded, Placebo-Controlled Study to Evaluate the Saftey and Efficacy of Oral LPCN 1154A in Women With Postpartum Depression
Study Start DateJune 15, 2025
Actual Primary Completion DateJanuary 15, 2026
Actual Study Completion DateFebruary 16, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
LPCN 1154A Tablets
LPCN 1154A
Drug: LPCN 1154A
Oral LPCN 1154A tablets for 48 hours
Placebo Tablets
Placebo Tablets
Drug: Placebo
Oral Placebo Tablets for 48 hours

Outcome Measures

Primary Outcome Measures
  1. Change from baseline in HAM-D17 total score compared to placebo
    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
  1. Incidence, severity, and causality of AEs and SAEs
    Adverse events (AEs) and Serious Adverse Events (SAEs)
  2. Change from baseline in HAM-D17 total score
    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.
  3. HAM-D17 response
    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.
  4. HAM-D17 remission
    Defined as having a HAM-D17 total score ≤7. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
  5. Patient Global Impression - Change (PGI-C) scale positive response
    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.
  6. Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
    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.
  7. Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score
    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.

Eligibility Criteria

Ages Eligible for Study(Child, Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsLipocine Inc.
Locations
Advanced Research Center | Anahiem California, United States, 92805Alliance Research Institute | Canoga Park California, United States, 91304MedOne Clinical Research, LLC | Miami Florida, United States, 33145D&H National Research Centers | Miami Florida, United States, 33155Meridian International Research | Miami Gardens Florida, United States, 33014Atlanta Behavioral Research | Atlanta Georgia, United States, 30338CenExel Research Center | Decatur Georgia, United States, 30030CenExel Research Center | Savannah Georgia, United States, 31405Clinical Research Prime | Idaho Falls Idaho, United States, 83404Cypress Medical Research Center, LLC | Kansas City Kansas, United States, 67226Best Clinical Trials | New Orleans Louisiana, United States, 70115Oasis Clinical Research | Las Vegas Nevada, United States, 89121Monroe Biomedical Research | Monroe North Carolina, United States, 28112Suburban Research Associates | Media Pennsylvania, United States, 19063Gadolin Research | Beaumont Texas, United States, 77702New Dawn Wellness and Medical Center | Houston Texas, United States, 77082Maximos OB/GYN | League City Texas, United States, 77573Populace Research | Provo Utah, United States, 84604