臨床研究等提出・公開システム

Date of registration	July. 26, 2019
Last modified on	July. 02, 2025
Trial ID	jRCTs021190007

Scientific Title	Approach to elucidate the effect of ketamine on treatment resistant depression (AKD)
Public Title	AKD (AKD)

Contact for Scientific Queries	Name	Kudo Takashi
	Affiliation	Hirosaki University Hospital
	Address	53 Honcho Hirosaki Aomori , Japan
	Telephone	+81-172335111
	E-mail	takf5@hirosaki-u.ac.jp
Contact for Public Queries	Name	Kudo Takashi
	Affiliation	Hirosaki University Hospital
	Address	53 Honcho Hirosaki Aomori , Japan
	Telephone	+81-172-33-5111
	E-mail	takf5@hirosaki-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 01, 2019
Actual date of first enrollment		Nov. 10, 2019
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	active control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	patients with refractory depression diagnosed by psychiatrists
	Exclusion Criteria	1. patients who has allergy to ketamine 2, patients who are diagnosed with glaucoma or high pressure of increased intracranial pressure
	Age Minimum	20age 0month 0week old over
	Age Maximum	65age 0month 0week old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		refractory depression
Intervention(s)		1.iv both ketamine 0.5 mg/kg and midazolam 0.04 mg/kg for 40 min 2. taking a blood sample
Health Condition(s) Keyword		depression
Primary Outcome(s)		effect of ketamine on refractory depression
Secondary Outcome(s)		assessment of biomarkers after intravenous injection of ketamine

Name of Certified Review Board	Hirosaki University General Certified Review Board
Address	1 Bunkyocho, Hirosaki , Aomori
Telephone	+81-172-39-5362
E-Mail	crb-hirosaki@hirosaki-u.ac.jp
Approval Status	Approval
Date of approval	July. 01, 2019

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	July. 02, 2025	(this page)	Changes
5	Sept. 05, 2024	Detail	Changes
4	April. 14, 2023	Detail	Changes
3	Jan. 06, 2022	Detail	Changes
2	July. 16, 2021	Detail	Changes
1	July. 26, 2019	Detail

List of change history