臨床研究等提出・公開システム

Date of registration	Jan. 23, 2022
Last modified on	June. 24, 2024
Trial ID	jRCT2031210577

Scientific Title	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
Public Title	A phase 3 study of S-812217 in patients with major depressive disorder

Contact for Scientific Queries	Name	Nagata Tsutae
	Affiliation	Shionogi & Co., Ltd
	Address	1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka
	Telephone	+81-6-6209-7885
	E-mail	shionogiclintrials-admin@shionogi.co.jp
Contact for Public Queries	Name	Corporate Communications Department
	Affiliation	Shionogi & Co., Ltd
	Address	1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka
	Telephone	+81-6-6209-7885
	E-mail	shionogiclintrials-admin@shionogi.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Jan. 12, 2022
Actual date of first enrollment		Mar. 08, 2022
Target sample size		400
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	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.
	Exclusion Criteria	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.
	Age Minimum	18age old over
	Age Maximum	75age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		depression
Intervention(s)		Part A: S-812217 or Placebo oral administration Part B: S-812217 oral administration
Primary Outcome(s)		Change from baselinea in HAM-D17 total score on Day 15 of Part A

Primary Sponsor	Shionogi & Co., Ltd.

Secondary Sponsor

Name of Certified Review Board	Yoyogi Mental Clinic Institutional Review Board
Address	3F, 4-26-11, Sendagaya, Shibuya-ku, Tokyo
Telephone	+81-3-6804-2227
E-Mail	cns_jimu@triad-j.co.jp
Approval Status	Approval
Date of approval	Jan. 28, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	June. 24, 2024	(this page)	Changes
2	July. 29, 2022	Detail	Changes
1	Jan. 23, 2022	Detail

List of change history