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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009444
Receipt No. R000011093
Scientific Title The neural base of the sense-of-self related emotions in a social anxiety-disorder patient: Analysis by a functional MRI
Date of disclosure of the study information 2012/12/01
Last modified on 2016/12/05

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Basic information
Public title The neural base of the sense-of-self related emotions in a social anxiety-disorder patient: Analysis by a functional MRI
Acronym The neural base of the sense-of-self related emotions in a social anxiety-disorder patient: Analysis by a functional MRI
Scientific Title The neural base of the sense-of-self related emotions in a social anxiety-disorder patient: Analysis by a functional MRI
Scientific Title:Acronym The neural base of the sense-of-self related emotions in a social anxiety-disorder patient: Analysis by a functional MRI
Region
Japan

Condition
Condition Social anxiety disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we try to detect the brain regions of social anxiety disorder patients which have relation with the effects of cognitive behavioral therapy using social anxiety tasks.
Moreover, the morbidity elucidation of social anxiety disorder is performed by comparing social anxiety disorder with a healthy person using the subject about sense-of-self related emotions as pilot study of this research.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Functional neuroimaging differences between pre-treatment and post-treatment in the intervention group
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Cognitive Behavioral therapy
Interventions/Control_2 Antidepressant
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
65 years-old >
Gender Male and Female
Key inclusion criteria Intervention group
1. Fulfill the criteria for generalized social anxiety disorder according to the Structured Clinical Interview for Diagnostic and Statistical Manual-4(DSM4)
2. From more than 20 years old to less than 65 years old
3. Have a wish to take cognitive behavioral therapy(CBT)
4. Give written informed consent
5. Right-handed

Control group
1. Fulfill the criteria for generalized social anxiety disorder according to the Structured Clinical Interview for DSM4
2. Social anxiety patients who match the patients in the intervention group in age and gender
3. Have been taken SSRI for 2 months and give informed consent that the dose of SSRI will continue unless the symptom becoming worse
4. Give written informed consent
5. Right-handed
Key exclusion criteria Intervention group
1. No history of current mood disorders or other anxiety disorders according to the Structured Clinical Interview for DSM4
2. No history of current substance abuse disorder, cluster A or B personality disorder, mental retardation and dementia according to clinical diagnosis
3. No previous CBT and agreement not to be involved in any other structured psychosocial therapies during treatment
4. Unsuitable to this intervention according to some reasons ex.)MRI, group therapy

Control group
1. No history of current mood disorders or other anxiety disorders according to the Structured Clinical Interview for DSM4
2. No history of current substance abuse disorder, cluster A or B personality disorder, mental retardation and dementia according to clinical diagnosis
3. No previous CBT and agreement not to be involved in any other structured psychosocial therapies during treatment
4. Unsuitable to this intervention according to some reasons ex.)MRI
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akiko Kawaguchi
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
Address Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN
TEL 052-853-8271
Email ig301043@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Kawaguchi
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
Address Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN
TEL 052-853-8271
Homepage URL
Email ig301043@yahoo.co.jp

Sponsor
Institute Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Nagoya city university hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 名古屋市立大学病院

Other administrative information
Date of disclosure of the study information
2012 Year 12 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 Completed
Date of protocol fixation
2012 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 04 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

Management information
Registered date
2012 Year 11 Month 30 Day
Last modified on
2016 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011093

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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