NCT06979544Phase 3Completed

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-01-16Actual

Enrollment · participants90Actual

Source updated2026-02-24Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-02-24 · 5 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~80 participants (planned)~~

+ After

90 participants (actual)

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~Apr 2026~~

+ After

16 Jan 2026

Recruitment status changed

− Before

~~Recruiting~~

+ After

Completed

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Study details

Conditions studied

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

Treatments or interventions studied

LPCN 1154ADrugAlso known as Brexanolone
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Change from baseline in HAM-D17 total score compared to placebo; description: 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.; timeFrame: Baseline to Hour 60

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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