UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009444 |
|---|---|
| Receipt number | 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 13:05:04 |
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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
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
ig301043@yahoo.co.jp
Sponsor or person
Institute
Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011093
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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