# SKYLARK trial (zuranolone in severe postpartum depression)

Study · id `maternal:skylark-trial` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public)

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Also called: 217-PPD-301

Browse, life stage: Postpartum  
Browse, care area: Mental health  

## In plain language

A trial that tested a 14-day course of zuranolone capsules in women with severe postpartum depression. Women were randomly given zuranolone 50 mg a day or a placebo, and neither the women nor the study team knew which. The US label names it as the first of the two studies that showed Zurzuvae works.

## Technical summary

Registry NCT04442503 (217-PPD-301): phase 3, randomised, parallel, quadruple-masked, placebo-controlled, lead sponsor Biogen (industry). Start 2020-06-08, primary completion 2022-03-15, completion 2022-04-12 (all actual); results first posted 2023-06-22; sites in the United States, Spain and the United Kingdom. Registry enrolment 200 (actual); the 2023 paper abstract prints 196 randomised (98 per group) of whom 170 (86.7%) completed the 45-day study, and the two counts are kept side by side. Primary outcome: change in 17-item HAM-D total score at day 15; secondary outcomes include days 3, 28 and 45. The name SKYLARK is taken from a 2024 indirect-comparison abstract that calls the zuranolone arm of the phase 3 SKYLARK Study (NCT04442503). The registry holds a results section, which the atlas does not copy. PubMed lists an erratum for the 2023 paper (PMID 39659161) that has no abstract and was not read, so the 196 and 98 counts and the other abstract figures are as printed in the abstract and may have been corrected. Findings are described in the claims on the zuranolone page; no structured findings are recorded because the atlas has no outcome record for HAM-D change.

## Key facts

- Design: Randomised, double-blind, placebo-controlled, parallel-group phase 3 trial of zuranolone 50 mg once daily for 14 days, with outcomes to day 45. Allocation 1:1. Registry masking: quadruple.
- Phase: Phase 3
- Enrolled: 200 participants (ClinicalTrials.gov gives no unit) (enrolled count; A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD), snapshot `maternal:ctgov-nct04442503-2026-10-14`, retrieved 2026-10-14); 196 patients (women with severe postpartum depression, from the paper abstract; PubMed lists an erratum for the paper, PMID 39659161, that was not read) (randomized count; Zuranolone for the Treatment of Postpartum Depression, snapshot `maternal:pubmed-37491938-2026-10-14`, retrieved 2026-10-14)
- Started: 2020-06-08 (actual) (A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD), snapshot `maternal:ctgov-nct04442503-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2022-03-15 (actual) (A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD), snapshot `maternal:ctgov-nct04442503-2026-10-14`, retrieved 2026-10-14)
- Completion: 2022-04-12 (actual) (A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD), snapshot `maternal:ctgov-nct04442503-2026-10-14`, retrieved 2026-10-14)
- Results first posted: 2023-06-22 (actual) (A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD), snapshot `maternal:ctgov-nct04442503-2026-10-14`, retrieved 2026-10-14)
- Countries: United States; Spain; United Kingdom (A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD), snapshot `maternal:ctgov-nct04442503-2026-10-14`, retrieved 2026-10-14)
- Care setting: Not reported
- Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `maternal:ctgov-nct04442503-2026-10-14`, retrieved 2026-10-14)

## Connected pages

- Tests zuranolone 50 mg a day for 14 days: Zuranolone (`maternal:zuranolone`)
- Named as Study 1 in the Zurzuvae label: Zurzuvae (zuranolone) (`maternal:zurzuvae`)

## Provenance

Content hash: ab698b0f0acad0abd31476b9adb2403ea2477e78b1b0f0f9e846b4622c3406cd
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14