Trial results for the study investigating brexanolone for depression in perimenopausal women (NCT05329779) were posted on ClinicalTrials.gov on 2026-01-22. This Phase 4 study, which aimed to explore the neurobiological underpinnings of perimenopausal depression, was terminated early after enrolling only two participants.
Background
The study, titled "Study on Allopregnanolone and Depression in Perimenopausal Women," sought to understand how the progesterone metabolite allopregnanolone influences behavior and neurobiology associated with perimenopausal depression. Brexanolone is a synthetic form of allopregnanolone.
Trial design
The study (NCT05329779) was a Phase 4 trial designed to investigate depression in perimenopausal women. It planned to include interventions with both brexanolone and placebo. The trial's overall status is listed as TERMINATED, with an enrollment of two participants.
What this means
The early termination of this Phase 4 study with minimal enrollment means that no actionable data on the efficacy or safety of brexanolone for perimenopausal depression could be gathered from this specific trial. The study's original aim to identify how allopregnanolone affects behavior and neurobiology in this population remains unaddressed by these trial results.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05329779, titled "Study on Allopregnanolone and Depression in Perimenopausal Women," were posted on 2026-01-22 on clinicaltrials.gov.