UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational prospective study of treatment for delirium
Title of the study (Brief title)	Observational prospective study of treatment for delirium
Region	Japan

Condition
Condition	Patients with delirium
Classification by specialty	Psychiatry
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the symptoms of delirium by Memorial delirium assessment scale(MDAS)befofe and after intervention for delirium.
Basic objectives2	Others
Basic objectives -Others	To study the association between the improvement factors of MDAS total/sub-score and drugs used for treatment of delirium, retrospectively.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The association between the improvement factors of MDAS total/sub-score and drugs used for treatment of delirium
Key secondary outcomes	The association between the improvement factors of MDAS sub-score and pharmacological profiles of drugs used for treatment of delirium

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.inpatients 2.delirious patients who treated with single drug
Key exclusion criteria	1.demented patients 2.alcohol withdrawal delirium 3.terminal delirium 4.aphasiac 5.in case of formulation change 6.in case of judging as exclusion by attending doctor
Target sample size	280

Research contact person
Name of lead principal investigator	Hitoshi Tanimukai
Organization	Osaka University Hospital
Division name	Oncology Center
Address	2-2,Yamadaoka, Suita, Osaka
TEL	06-6879-3051
Email	tanimuki@psy.med.osaka-u.ac.jp

Public contact
Name of contact person	Hitoshi Tanimukai
Organization	Osaka University Graduate School of Medicine
Division name	Department of Psychiatry
Address	2-2,Yamadaoka, Suita, Osaka
TEL	06-6879-3051
Homepage URL
Email	tanimuki@psy.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	NOne
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	大阪大学医学部附属病院　Osaka University Hospital

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 09 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry	2015 Year 11 Month 30 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Trial will be strated from April 1 in 2013.
Other related information	Evaluate the clinical symptoms of delirious patients by MDAS.

Management information
Registered date	2013 Year 04 Month 10 Day
Last modified on	2016 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012019