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SKYLARK trial (zuranolone in severe postpartum depression)

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.

Also called 217-PPD-301

  • Study
  • In this atlas

Overview

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), retrieved )
  • 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, retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • NCT NCT04442503
  • EudraCT 2020-001424-34
Started
(actual) (A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD), retrieved )
Primary completion
(actual) (A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD), retrieved )
Completion
(actual) (A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD), retrieved )
Results first posted
(actual) (A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD), retrieved )
Countries
United States, Spain, United Kingdom (A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD), retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

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.

Arms

  • Zuranolone 50 mg

    Intervention Zuranolone

    Zuranolone 50 mg capsules by mouth once daily for 14 days (registry arm SAGE-217 50 mg).

  • Placebo

    Intervention None named

    Matched placebo capsules by mouth once daily for 14 days.

Findings

No findings are published for this study.

Record details

Record id
maternal:skylark-trial
Content hash
ab698b0f0acad0abd31476b9adb2403ea2477e78b1b0f0f9e846b4622c3406cd