UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The neural base of the sense-of-self related emotions in a social anxiety-disorder patient: Analysis by a functional MRI
Title of the study (Brief title)	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	Akiko Kawaguchi
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Psychiatry and Cognitive-Behavioral Medicine
Address	Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN
TEL	052-853-8271
Email	ig301043@yahoo.co.jp

Public contact
Name of contact person	Akiko Kawaguchi
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Psychiatry and Cognitive-Behavioral Medicine
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011093