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

Lipocine

Status and phase: Begins enrollment this month; Phase 3

Conditions: Depression, Post-Partum; Depression, Postpartum; Postpartum Depression (PPD); Peripartum Depression; Post-Natal Depression; Postnatal Depression

Treatments: Drug: Placebo; Drug: LPCN 1154A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06979544

LPCN 1154-24-002a

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

LPCN 1154A Tablets

Experimental group

Description:

LPCN 1154A

Treatment:

Drug: LPCN 1154A

Placebo Tablets

Placebo Comparator group

Description:

Placebo Tablets

Treatment:

Drug: Placebo