UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Behavioral study of conscious awareness of voluntary action and reward in psychiatric diseases.
Title of the study (Brief title)	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	Motoichiro Kato
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	Shinanomachi35
TEL
Email

Public contact
Name of contact person
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011067