UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized clinical trial of delirium prevention
Title of the study (Brief title)	A randomized clinical trial of delirium prevention
Region	Japan

Condition
Condition	delirium
Classification by specialty	Psychiatry Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to examine whether suvorexant is effective for prevention of delirium, or not.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of delirium
Key secondary outcomes	Discontinuation due to adverse phenomenon

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Suvorexant 7days between 20 and 64 years of age :20mg 65 years ofage and older :15mg
Interventions/Control_2	Conventional treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients newly admitted to emergency department
Key exclusion criteria	1) Alcohol dependence, amphetamine abuse 2) under medication with psychoactive drug
Target sample size	70

Research contact person
Name of lead principal investigator	Kazunari Azuma
Organization	Tokyo Medical University Hospital
Division name	emergency and critical care medicine
Address	6-7-1 Nishishinjyuku,Shinjyuku-ku,Tokyo
TEL	03-3342-6111
Email	jpn4077@yahoo.co.jp

Public contact
Name of contact person	Kazunari Azuma
Organization	Tokyo Medical University Hospital
Division name	emergency and critical care medicine
Address	6-7-1 Nishishinjyuku,Shinjyuku-ku,Tokyo
TEL	03-3342-6111
Homepage URL
Email	jpn4077@yahoo.co.jp

Sponsor
Institute	Tokyo Medical University Hospital
Institute
Department

Funding Source
Organization	Tokyo Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京医科大学病院(東京都)　　　　　　Tokyo Medical University(Tokyo)

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
Anticipated trial start date	2015 Year 05 Month 12 Day
Last follow-up date	2017 Year 02 Month 28 Day
Date of closure to data entry	2017 Year 02 Month 28 Day
Date trial data considered complete	2017 Year 03 Month 10 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 07 Day
Last modified on	2017 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019132