UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008580 |
|---|---|
| Receipt number | R000010015 |
| Scientific Title | Sense of agency task(Keio method): diagnostic marker for mental disorders |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2012/07/31 15:50:16 |
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Basic information
Public title
Sense of agency task(Keio method):
diagnostic marker for mental disorders
Acronym
Sense of agency task(Keio method)
Scientific Title
Sense of agency task(Keio method):
diagnostic marker for mental disorders
Scientific Title:Acronym
Sense of agency task(Keio method)
Region
| Japan |
Condition
Condition
mental disorders(schizophrenia, bipoler disorder etc.)
Classification by specialty
| Neurology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The nature of these self-disturbances is hardly studied in neuroscience, because self-disturbances represent subjective experiences and can only be described by the first-person perspective of the patient. However, in recent years, focus has shifted to self-consciousness in cognitive neuroscience, and especially to the "sense of agency". We devised an agency attribution task that evaluated explicit experiences of temporal causal relation between an intentional action and an external event, without any confounding from sense of ownership of body movement.
We designed longitudinal studies for mental disorders.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1.cognitive function
sense of agency task[Keio Method]
2.clinical assesment
PANSS
GAF
SIPS[only for prodromal state]
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Mental disorders[schizophrneia, bipoler disorder etc.]according to the DSM-IV criteria were recruited from Keio University Hospital and Sakuragaoka Memorial Hospital in Japan.
Key exclusion criteria
Patients suffering from critical physical conditions were excluded from the study.
And, patients with severe mental state were also excluded.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaki Maeda |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaki Maeda |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
takaki@xa3.so-net.ne.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japanese Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sakuragaoka Memorial Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
in submission
Management information
Registered date
| 2012 | Year | 07 | Month | 31 | Day |
Last modified on
| 2012 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010015
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
