Efficacy and safety of zuranolone in Japanese adults with major depressive disorder: A double‐blind, randomized, placebo‐controlled, phase 2 clinical trial.
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| Title: | Efficacy and safety of zuranolone in Japanese adults with major depressive disorder: A double‐blind, randomized, placebo‐controlled, phase 2 clinical trial. |
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| Authors: | Kato, Masaki (AUTHOR), Nakagome, Kazuyuki (AUTHOR), Baba, Takamichi (AUTHOR), Sonoyama, Takuhiro (AUTHOR), Okutsu, Daiki (AUTHOR), Yamanaka, Hideki (AUTHOR), Shimizu, Ryosuke (AUTHOR), Motomiya, Tomoko (AUTHOR), Inoue, Takeshi (AUTHOR) |
| Source: | Psychiatry & Clinical Neurosciences. Sep2023, Vol. 77 Issue 9, p497-509. 13p. 1 Diagram, 5 Charts, 4 Graphs. |
| Subjects: | Japanese people, Mental depression, Hamilton Depression Inventory, Clinical trials |
| Geographic Terms: | Japan |
| Abstract: | Aim: To evaluate the efficacy and safety of an oral, once‐daily, 14‐day treatment course of zuranolone in Japanese patients with major depressive disorder (MDD). Methods: This multicenter, randomized, double‐blind, placebo‐controlled study randomized eligible patients (1:1:1) to receive oral zuranolone 20 mg, zuranolone 30 mg, or placebo once daily for 14 days (treatment‐period), followed by two 6‐week follow‐up periods. The primary endpoint was change from baseline in the 17‐item Hamilton Depression Rating Scale (HAMD‐17) total score on Day 15. Results: Overall, 250 patients (enrolled: 07/07/2020–05/26/2021) were randomized to receive placebo (n = 83), zuranolone 20 mg (n = 85), or zuranolone 30 mg (n = 82). The demographic and baseline characteristics were balanced between groups. The adjusted mean (standard error) change from baseline in the HAMD‐17 total score on Day 15 was −6.22 (0.62), −8.14 (0.62), and − 8.31 (0.63) in the placebo, zuranolone 20‐mg, and zuranolone 30‐mg groups, respectively. Significant differences in the adjusted mean (95% confidence interval [CI]) for zuranolone 20 mg versus placebo (−1.92; [−3.65, −0.19]; P = 0.0296) and zuranolone 30 mg versus placebo (−2.09; [−3.83, −0.35]; P = 0.0190) groups were observed on Day 15, and also as early as Day 3. A nonsignificant yet distinct drug‐placebo separation was observed during follow‐up. Somnolence (placebo [3.7%], zuranolone 20 mg [10.6%], and zuranolone 30 mg [20.7%]) and dizziness (3.7%, 9.4%, and 9.8%, respectively) were more common with zuranolone. Conclusion: Oral zuranolone was safe and demonstrated significant improvements in depressive symptoms, as assessed by HAMD‐17 total score change from baseline over 14 days in Japanese patients with MDD. [ABSTRACT FROM AUTHOR] |
| Copyright of Psychiatry & Clinical Neurosciences is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 171369390 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Efficacy and safety of zuranolone in Japanese adults with major depressive disorder: A double‐blind, randomized, placebo‐controlled, phase 2 clinical trial. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Kato%2C+Masaki%22">Kato, Masaki</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Nakagome%2C+Kazuyuki%22">Nakagome, Kazuyuki</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Baba%2C+Takamichi%22">Baba, Takamichi</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sonoyama%2C+Takuhiro%22">Sonoyama, Takuhiro</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Okutsu%2C+Daiki%22">Okutsu, Daiki</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Yamanaka%2C+Hideki%22">Yamanaka, Hideki</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Shimizu%2C+Ryosuke%22">Shimizu, Ryosuke</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Motomiya%2C+Tomoko%22">Motomiya, Tomoko</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Inoue%2C+Takeshi%22">Inoue, Takeshi</searchLink> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Psychiatry+%26+Clinical+Neurosciences%22">Psychiatry & Clinical Neurosciences</searchLink>. Sep2023, Vol. 77 Issue 9, p497-509. 13p. 1 Diagram, 5 Charts, 4 Graphs. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Japanese+people%22">Japanese people</searchLink><br /><searchLink fieldCode="DE" term="%22Mental+depression%22">Mental depression</searchLink><br /><searchLink fieldCode="DE" term="%22Hamilton+Depression+Inventory%22">Hamilton Depression Inventory</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink> – Name: SubjectGeographic Label: Geographic Terms Group: Su Data: <searchLink fieldCode="DE" term="%22Japan%22">Japan</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Aim: To evaluate the efficacy and safety of an oral, once‐daily, 14‐day treatment course of zuranolone in Japanese patients with major depressive disorder (MDD). Methods: This multicenter, randomized, double‐blind, placebo‐controlled study randomized eligible patients (1:1:1) to receive oral zuranolone 20 mg, zuranolone 30 mg, or placebo once daily for 14 days (treatment‐period), followed by two 6‐week follow‐up periods. The primary endpoint was change from baseline in the 17‐item Hamilton Depression Rating Scale (HAMD‐17) total score on Day 15. Results: Overall, 250 patients (enrolled: 07/07/2020–05/26/2021) were randomized to receive placebo (n = 83), zuranolone 20 mg (n = 85), or zuranolone 30 mg (n = 82). The demographic and baseline characteristics were balanced between groups. The adjusted mean (standard error) change from baseline in the HAMD‐17 total score on Day 15 was −6.22 (0.62), −8.14 (0.62), and − 8.31 (0.63) in the placebo, zuranolone 20‐mg, and zuranolone 30‐mg groups, respectively. Significant differences in the adjusted mean (95% confidence interval [CI]) for zuranolone 20 mg versus placebo (−1.92; [−3.65, −0.19]; P = 0.0296) and zuranolone 30 mg versus placebo (−2.09; [−3.83, −0.35]; P = 0.0190) groups were observed on Day 15, and also as early as Day 3. A nonsignificant yet distinct drug‐placebo separation was observed during follow‐up. Somnolence (placebo [3.7%], zuranolone 20 mg [10.6%], and zuranolone 30 mg [20.7%]) and dizziness (3.7%, 9.4%, and 9.8%, respectively) were more common with zuranolone. Conclusion: Oral zuranolone was safe and demonstrated significant improvements in depressive symptoms, as assessed by HAMD‐17 total score change from baseline over 14 days in Japanese patients with MDD. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Psychiatry & Clinical Neurosciences is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=171369390 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1111/pcn.13569 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 13 StartPage: 497 Subjects: – SubjectFull: Japanese people Type: general – SubjectFull: Mental depression Type: general – SubjectFull: Hamilton Depression Inventory Type: general – SubjectFull: Clinical trials Type: general – SubjectFull: Japan Type: general Titles: – TitleFull: Efficacy and safety of zuranolone in Japanese adults with major depressive disorder: A double‐blind, randomized, placebo‐controlled, phase 2 clinical trial. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Kato, Masaki – PersonEntity: Name: NameFull: Nakagome, Kazuyuki – PersonEntity: Name: NameFull: Baba, Takamichi – PersonEntity: Name: NameFull: Sonoyama, Takuhiro – PersonEntity: Name: NameFull: Okutsu, Daiki – PersonEntity: Name: NameFull: Yamanaka, Hideki – PersonEntity: Name: NameFull: Shimizu, Ryosuke – PersonEntity: Name: NameFull: Motomiya, Tomoko – PersonEntity: Name: NameFull: Inoue, Takeshi IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 09 Text: Sep2023 Type: published Y: 2023 Identifiers: – Type: issn-print Value: 13231316 Numbering: – Type: volume Value: 77 – Type: issue Value: 9 Titles: – TitleFull: Psychiatry & Clinical Neurosciences Type: main |
| ResultId | 1 |
