RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Randomized, Blinded, Placebo-Controlled Study to Evaluate the Saftey and Efficacy of Oral LPCN 1154A in Women With Postpartum Depression

Quick Facts

Study Start:2025-06
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06979544

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Are female between 15 and 45 years of age, inclusive;
  2. * Have had a depressive episode that began no earlier than third trimester and later than the first 4 week following delivery
  3. * Are \< 12 months postpartum at Screening
  4. * Hamilton Depression Rating Scale (HAM-D) 17-item score indicative of severe depression
  1. * Have a history of bipolar disorder, schizophrenia or schizoaffective disorder
  2. * Are currently experiencing active psychosis per Investigator assessment
  3. * Have a history of suicidal behavior within 1 year
  4. * Have a history of seizure within 6 months of Screening

Contacts and Locations

Study Contact

Vice President of Clinical Development
CONTACT
801-994-7383
bjb@lipocine.com

Study Locations (Sites)

Advance Research Center
Anahiem, California, 92805
United States
Alliance Research Institute
Canoga Park, California, 91304
United States
Excell Research, Inc.
Oceanside, California, 92056
United States
Meridian International Research
Miami Gardens, Florida, 33014
United States
MedOne Clinical Research, LLC
Miami, Florida, 33145
United States
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
United States
CenExel Research Center
Decatur, Georgia, 30030
United States
Pillar Clinical Research
Chicago, Illinois, 60641
United States
Maximos OB/GYN
League City, Texas, 77573
United States
Populace Research
Provo, Utah, 84604
United States

Collaborators and Investigators

Sponsor: Lipocine Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06
Study Completion Date2026-05

Study Record Updates

Study Start Date2025-06
Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

  • Depression, Postpartum
  • Depression, Post-Partum
  • Postpartum Depression (PPD)
  • Post-Natal Depression
  • Peripartum Depression
  • Postnatal Depression