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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019297
Receipt No. R000022284
Scientific Title The effect of pharmacotherapy and psychosocial therapy on cognitive function and life style
Date of disclosure of the study information 2015/10/09
Last modified on 2019/04/15

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Basic information
Public title The effect of pharmacotherapy and psychosocial therapy on cognitive function and life style
Acronym The effect of pharmacotherapy and psychosocial therapy on cognitive function and life style
Scientific Title The effect of pharmacotherapy and psychosocial therapy on cognitive function and life style
Scientific Title:Acronym The effect of pharmacotherapy and psychosocial therapy on cognitive function and life style
Region
Japan

Condition
Condition Schizophrenia, mood disorder, dementia (mild), eating disorder, sleep disorder, autism spectrum disorder, breathing-related sleep disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of pharmacotherapy and psychosocial therapy on cognitive function, quality of life, and daily life
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Driving performance by driving simulator
Key secondary outcomes Sexual function screening, cognitive function (attention, memory, executive function), ocular motion, sleep sheet, compact electroencephalograph, assessment of psychiatric symptoms, assessment of driving behavior

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 with schizophrenia, mood disorder, sleep disorder, autism spectrum disorder, or breathing related sleep disorder who give consent to to study participation
Key exclusion criteria under 20 years old
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Norio
Middle name
Last name Ozaki
Organization Nagoya University Graduate School of Medicine
Division name Psychiatry
Zip code 466-8550
Address Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan
TEL +81527442282
Email ozaki-n@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Kunihiro
Middle name
Last name Iwamoto
Organization Nagoya University Graduate School of Medicine
Division name Psychiatry
Zip code 466-8550
Address Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan
TEL +81527442282
Homepage URL
Email iwamoto@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nagoya University Graduate School of Medicine and Nagoya University Hospital ethics review committee
Address Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan
Tel 052-744-2479
Email ethics@med.nagoya-u.ac.jp

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

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2010 Year 04 Month 12 Day
Date of IRB
2010 Year 04 Month 12 Day
Anticipated trial start date
2010 Year 04 Month 12 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Based on case-control and longitudinal model. We recruit a healthy adult without history of psychiatric disorders

Management information
Registered date
2015 Year 10 Month 09 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022284

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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