A phase 3 study of S-812217 in patients with major depressive disorder consisting of randomized, double-blind, placebo-control part and extension, open-label, re-treatment part

Shionogi & Co., Ltd.0 个研究点目标入组 400 人开始时间: 2022年3月8日最近更新: 2024年6月24日

适应症

试验速览

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•Patients who have been interviewed using Mini-International Neuropsychiatric Interview (M.I.N.I.) and had diagnosis of depression according to the DSM-5, and who meet the following 2 conditions:
•> The current episode is ongoing for at least 8 weeks prior to the day of signing the ICF.
•> Duration of current episode is 12 months or less prior to signing the ICF.

•Patients with treatment-resistant depression; no improvement in depressive symptoms even though at least two different antidepressants, except for antipsychotics, have been administered for treatment of an existing depressive episode at adequate doses approved in the countries for 4 weeks. The Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) will be evaluated only at Visit 1.

Change from baselinea in HAM-D17 total score on Day 15 of Part A

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发起方