UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bio-psycho-social Risk Factors for Delirium and Depression in Patients Undergoing Allogeneic Hematopoietic Stem-Cell Transplantation
Title of the study (Brief title)	Psychiatric Symptoms in Patients Undergoing Allogeneic Hematopoietic Stem-Cell Transplantation
Region	Japan

Condition
Condition	Hematopoietic tumors
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To Determine The Bio-psycho-social Risk Factors for Delirium and Depression in Patients Undergoing Allogeneic Hematopoietic Stem-Cell Transplantation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Delirium Rating Scale -R-98 (DRS-R-98) Memorial Delirium Assessment Scale (MDAS) Structured Clinical Interview for DSM-IV (SCID) Patient Health Questionnaire-9 (PHQ-9)
Key secondary outcomes	Hospital Anxiety and Depression Scale (HADS) Visual Analog Scale (VAS) 36-item Short-Form Health Survey (SF-36) Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT) Brief Evaluation of Medication Influence and Beliefs (BEMIB) Social Support Questionnaire (SSQ) Temperament and Character Inventory-125 (TCI-125)

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	Patients To Undergo Allogeneic Hematopoietic Stem-Cell Transplantation In Nagoya Universty Hospital Who Ware Obtained Written Informed Consent After a Full Explanation Of The Study
Key exclusion criteria	Patients Who can Not Understand Japanese Patients Who can Not Understand The Explanation Of The Study With Dementia, Disturbance of Consciousness and Psychiatric Desorders Patients Who Do Not Consent The Study
Target sample size	80

Research contact person
Name of lead principal investigator	Norio Ozaki
Organization	Nagoya University Graduate School Of Medicine
Division name	Department of Psyichiatry
Address	Tsyrumaicho 65, showa-ku, Nagoya City, Aichi, Japan
TEL	+81527442282
Email	ozaki-n@med.nagoya-u.ac.jp

Public contact
Name of contact person	Hiroyuki Kimura
Organization	Nagoya University Graduate School Of Medicine
Division name	Department of Psyichiatry
Address	Tsyrumaicho 65, showa-ku, Nagoya City, Aichi, Japan
TEL	+81527442282
Homepage URL
Email	kimurahi@mad.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School Of Medicine
Institute
Department

Funding Source
Organization	Grant-in-Aid For Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	名古屋大学医学部附属病院（愛知県）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 20 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 07 Month 05 Day
Anticipated trial start date	2012 Year 07 Month 05 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	Longitudinal Model

Management information
Registered date	2018 Year 03 Month 20 Day
Last modified on	2018 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036341