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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009419
Receipt No. R000011067
Scientific Title Behavioral study of conscious awareness of voluntary action and reward in psychiatric diseases.
Date of disclosure of the study information 2012/11/28
Last modified on 2017/06/07

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Basic information
Public title Behavioral study of conscious awareness of voluntary action and reward in psychiatric diseases.
Acronym Behavioral study of conscious awareness of voluntary action and reward in psychiatric diseases.
Scientific Title Behavioral study of conscious awareness of voluntary action and reward in psychiatric diseases.
Scientific Title:Acronym Behavioral study of conscious awareness of voluntary action and reward in psychiatric diseases.
Region
Japan

Condition
Condition Mood disorders, schizophrenia, brain injury
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to develop behavioral marker of psychiatric diseases by investigating modification of conscious awareness of voluntary action by rewards.
Basic objectives2 Others
Basic objectives -Others Performance of cognitive task
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjective temporal interval between voluntary actions and effects
Key secondary outcomes Cognitive scales (IAPS,HAM-D,BDI,TCI)

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
60 years-old >
Gender Male and Female
Key inclusion criteria Healthy subjects
1.Subjects without past history of psychiatric diseases
2.Subjects who can understand purpose of the present study and have ability to give informed consent.
3.Subjects who can perform experiments as experimenter instructed.

Patients
1.Patients who have been diagnosed with schizophrenia, mood disorders or brain injury based on past history and brain imaging such as MRI and CT.
2.Subjects who can understand purpose of the present study and have ability to give informed consent
3.Subjects who can perform experiments as experimenter instructed.
Key exclusion criteria Healthy subjects
1.Subjects who have psychiatric or physical diseases that affects performance of the task.
2.Subjects who have severe physical diseases.

Patients
1.Subjects who have psychiatric or physical diseases that affects performance of the task.
2.Patients who lack ability to give informed consent.
3.Subjects who have severe physical diseases.
4.Subjects who have difficulties with performing the task.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoichiro Kato
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address Shinanomachi35
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address
TEL 03-5363-3829
Homepage URL
Email

Sponsor
Institute Keio University School of Medicine
Department of Neuropsychiatry
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 28 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 Completed
Date of protocol fixation
2012 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
2013 Year 12 Month 31 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information Prospective study and random sampling

Management information
Registered date
2012 Year 11 Month 28 Day
Last modified on
2017 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011067

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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