UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan PHarmacological Audit study of Safety and Efficacy in Realworld (Phase-R) Delirium Study
Title of the study (Brief title)	Phase-R Delirium Study
Region	Japan

Condition
Condition	Malignancy
Classification by specialty	Medicine in general Psychosomatic Internal Medicine Psychiatry
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of antipsychotic treatments for delirium in palliative care units and psychooncology consultation settings.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Delirium Rating Scale R-98 on day 3
Key secondary outcomes	NuDESC item 2-4 Communication Capacity Scale item 4 Agitation Distress Scale item 2 Adverse events Drug-induced Extra-piramidal Symptom Scale(DIEPSS)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Inpatients with advanced cancer aged 18 years or older who undergo antipsychotic treatments for hyper- or hypoactive delirium in palliative care units or psycho-oncology consultation settings
Key exclusion criteria	Patients with substance withdrawal delirium Patient with postoperative delirium Patients who undergo medical treatments intended to terminal sedation
Target sample size	1000

Research contact person
Name of lead principal investigator	Asao Ogawa
Organization	National Cancer Center East
Division name	Psycho-Oncology Division
Address	6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
TEL	04-7133-1111
Email	asogawa@east.ncc.go.jp

Public contact
Name of contact person	Keisuke Ariyoshi
Organization	The University of Tokyo, The Institute of Medical Science
Division name	Department of Palliative Medicine
Address	4-6-1 Shiroganedai, Minato-ku, Tokyo, Japan
TEL	03-3443-8111
Homepage URL	http://www.jortc.jp/
Email	k-ariyoshi@umin.ac.jp

Sponsor
Institute	The University of Tokyo, The Institute of Medical Science
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
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

国立がん研究センター東病院（千葉県） 国立がん研究センター中央病院（東京都） 名古屋市立大学大学院（愛知県） 岡山大学病院（岡山県） 千葉県がんセンター（千葉県） 市立札幌病院（北海道） 埼玉県立がんセンター（埼玉県） 東京大学医学部附属病院（東京都） 滋賀医科大学（滋賀県） 国立病院機構　近畿中央胸部疾患センター（大阪府） 慶應義塾大学病院（東京都） 聖隷三方原病院（静岡県） 小牧市民病院（岐阜県） 外旭川病院（秋田県） 川崎市立井田病院かわさき総合ケアセンター（神奈川県） 筑波メディカルセンター病院（茨城県） ガラシア病院（大阪府） 聖路加国際病院（東京都） 栃木県立がんセンター（栃木県） 岡山済生会総合病院（岡山県） 六甲病院（兵庫県） 大阪市立総合医療センター（大阪府） 東北大学病院（宮城県） 島根大学医学部附属病院（島根県） JCHO東京新宿メディカルセンター（東京都） 兵庫県立加古川医療センター（兵庫県） 永寿総合病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 09 Day
Anticipated trial start date	2015 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Safety (Day7) and efficacy (Day3) of antipsychotic treatments for hyper- and hypoactive delirium will be evaluated

Management information
Registered date	2015 Year 08 Month 07 Day
Last modified on	2018 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018657