Safety and efficacy of zuranolone in Japanese adults with major depressive disorder: An open‐label, repeated‐treatment part of a Phase 3 clinical trial

In this open-label part of the Phase 3 study in Japan, zuranolone decreased the HAMD-17 total scores from baseline over 15 days during repeated treatment cycles in patients with major depressive disorder, without any new safety signals.

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Publication Details

Journal
Psychiatry and Clinical Neurosciences Reports
Published
2026-02-19
DOI
https://doi.org/10.1002/pcn5.70302
Primary Topic
Treatment of Major Depression
Type
article
Field-Weighted Citation Impact
0.00

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article

Safety and efficacy of zuranolone in Japanese adults with major depressive disorder: An open‐label, repeated‐treatment part of a Phase 3 clinical trial

Takamichi Baba, Masaki Kato, Takuhiro Sonoyama, Tomoko Motomiya et al.
Psychiatry and Clinical Neurosciences Reports
Treatment of Major Depression
article

Safety and efficacy of zuranolone in Japanese adults with major depressive disorder: An open‐label, repeated‐treatment part of a Phase 3 clinical trial

Takamichi Baba, Masaki Kato, Takuhiro Sonoyama, Tomoko Motomiya, Hiroki Fukuju, Kazuyuki Nakagome, Ryosuke Shimizu, Takeshi Inoue, Juan Carlos Gomez
article en

Abstract

In this open-label part of the Phase 3 study in Japan, zuranolone decreased the HAMD-17 total scores from baseline over 15 days during repeated treatment cycles in patients with major depressive disorder, without any new safety signals.

Psychiatry and Clinical Neurosciences ReportsVol. 5(1)
Kansai Medical University (JP), Tokyo Medical University (JP), Centre for Innovation in Regulatory Science (GB), National Center of Neurology and Psychiatry (JP), Shionogi (Japan) (JP), Hanazono Hospital (JP), Futaba (Japan) (JP)
Sage Therapeutics, Supernus Pharmaceuticals, Shionogi
Good health and well-being
Openalex Percentile: Top 50%
Treatment of Major Depression
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