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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010706
Receipt No. R000012510
Scientific Title A randomized clinical trial of delirium treatment
Date of disclosure of the study information 2013/06/30
Last modified on 2014/05/16

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Basic information
Public title A randomized clinical trial of delirium treatment
Acronym A randomized clinical trial of delirium treatment
Scientific Title A randomized clinical trial of delirium treatment
Scientific Title:Acronym A randomized clinical trial of delirium treatment
Region
Japan

Condition
Condition delirium
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine whether quetiapine and perospirone are superior to risperidone in the treatment of delirium.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Time to first resolution of delirium
Key secondary outcomes response rate
discontinuation rate due to side effects

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 quetiapine
Interventions/Control_2 perospirone
Interventions/Control_3 risperidone
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
65 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients devoloping delirium during admission due to somatic diseases
Delirium diagnosed according to DSM-IV-TR
The score of DRS-R98: >14.5
Key exclusion criteria 1) diabetes mellitis
2) severe liver dysfunction
3) under medication with antipsychotics
4) under medication with opioid
5) alcohol withdrawal
Target sample size 108

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kotaro Hatta
Organization Juntendo University Nerima Hospital
Division name Department of Psychiatry
Zip code
Address 3-1-10 Takanodai, Nerima-ku, Tokyo 177-8521
TEL 03-5923-3111
Email khatta@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kotaro Hatta
Organization Juntendo University Nerima Hospital
Division name Department of Psychiatry
Zip code
Address 3-1-10 Takanodai, Nerima-ku, Tokyo 177-8521
TEL 03-5923-3111
Homepage URL
Email khatta@juntendo.ac.jp

Sponsor
Institute Juntendo University Nerima Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science (the Ministry of Education, Culture, Sports, Science & Technology in Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Nippon Medical School Musashikosugi Hospital
Tokyo Medical and Dental University
Hiroshima City Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 順天堂大学医学部附属練馬病院(東京都)
日本医科大学武蔵小杉病院(神奈川県)
東京医科歯科大学(東京都)
広島市立広島市民病院(広島県)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2013 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2014 Year 04 Month 07 Day
Date of closure to data entry
2014 Year 04 Month 30 Day
Date trial data considered complete
2014 Year 05 Month 31 Day
Date analysis concluded
2014 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 13 Day
Last modified on
2014 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012510

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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