RECRUITING

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

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

Conditions

Depression, PostpartumDepression, Post-PartumPostpartum Depression (PPD)Post-Natal DepressionPeripartum DepressionPostnatal Depression
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Related Conditions:

Depression, PostpartumDepression, Post-PartumPostpartum Depression (PPD)Post-Natal DepressionPeripartum DepressionPostnatal Depression

Study Overview

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Study Details

Study overview

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

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

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

Condition
Depression, Postpartum
Intervention / Treatment

-

Contacts and Locations

Anahiem

Advance Research Center, Anahiem, California, United States, 92805

Canoga Park

Alliance Research Institute, Canoga Park, California, United States, 91304

Oceanside

Excell Research, Inc., Oceanside, California, United States, 92056

Miami Gardens

Meridian International Research, Miami Gardens, Florida, United States, 33014

Miami

MedOne Clinical Research, LLC, Miami, Florida, United States, 33145

Pompano Beach

Clinical Research Center of Florida, Pompano Beach, Florida, United States, 33060

Decatur

CenExel Research Center, Decatur, Georgia, United States, 30030

Chicago

Pillar Clinical Research, Chicago, Illinois, United States, 60641

League City

Maximos OB/GYN, League City, Texas, United States, 77573

Provo

Populace Research, Provo, Utah, United States, 84604

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

15 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Lipocine Inc.,

Study Record Dates

2026-05