Brexanolone Lifting Outcomes Of Moms

Phase 3RecruitingNCT07822321

Lipocine Inc.120 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Depression, Postpartum Postpartum Depression (PPD)Post-partum Depression Postnatal Depression Post-Natal Depression Peripartum Depression

Interventions

LPCN 1154ADRUG

Oral LPCN 1154A tablets for 48 hours

PlaceboDRUG

Oral Placebo Tablets for 48 hours

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 45 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Are female between 15 and 45 years of age, inclusive; * Have had a depressive episode that began no earlier than second trimester and no later than the first 4 weeks following delivery * Are \< 18 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 associated with the current depressive episode * Have a history of seizure within six months of Screening

Locations (16)

Lipocine Investigational Site

Tucson, Arizona, United States

RECRUITING

Lipocine Investigational Site

Outcomes

Primary Outcomes

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 activities, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, genital symptoms, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.

Time frame: Baseline to Hour 60

Secondary Outcomes

Change from baseline in HAM-D17 total score

Time frame: Baseline to Hour 12 and Day 30

Change from baseline Clinical Global Impression of Severity (CGI-S) scale positive response

The CGI-S scale is a 7-point scale that requires the Investigator to assess the severity of a patient's illness. Scores range from 1 -normal, not at all ill to 7 - among the most extremely ill patients

Time frame: Baseline to Hour 12, Hour 60 and Day 30

Central Contacts

Vice President of Clinical Development

CONTACT

801-519-4363 siteinquiry@lipocine.com

Data from ClinicalTrials.gov

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