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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042013
Receipt No. R000047948
Scientific Title Structural and resting-state functional abnormalities in patients with panic disorder: whole brain analysis
Date of disclosure of the study information 2021/01/01
Last modified on 2020/10/05

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Basic information
Public title Structural and functional abnormalities in brain white matter in panic disorder
Acronym Structural and functional abnormalities in brain white matter in panic disorder
Scientific Title Structural and resting-state functional abnormalities in patients with panic disorder: whole brain analysis
Scientific Title:Acronym Structural and resting-state functional abnormalities in patients with panic disorder: whole brain analysis
Region
Japan

Condition
Condition panic disorder, healthy control subject
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate abnormalities in structural and resting state functional connectivity in patients with panic disorder compared to healthy control subjects for uncovering neurobiological basis of panic disorder
Basic objectives2 Others
Basic objectives -Others Evaluating relationships between structural and functional abnormalities in white matter and clinical measures and autonomic function in patients with panic disorder.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Uncovering local white matter regions showing structural and functional abnormalities in patients with panic disorder compared with healthy control subjects.
Key secondary outcomes Associations between structural and functional abnormalities in white matter and clinical measures and autonomic function in patients with panic disorder.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 white matter structure (MRI examination only once)
Interventions/Control_2 resting state functional connectivity (MRI examination only once)
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 patients with panic disorder, healthy control subject
no history of loss of consciousness
no history of addiction of drug and so on
no history of neurological disorder
subject who can understand this study and giving us written informed consent

Key exclusion criteria (1) subjects having metal in body
(2) subjects with pregnancy
(3) IQ: less then 70
(4) patients with panic disorder with other mental disorders expect for past history of depression.

Target sample size 60

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Asami
Organization Yokohama City University
Division name Department of Psychiatry
Zip code 236004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL 0457872667
Email t_asami@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Asami
Organization Yokohama City University
Division name Department of Psychiatry
Zip code 236004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL 0457872667
Homepage URL
Email t_asami@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Funding Source
Organization Department of Psychiatry, Yokohama City University
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yokohama City University Hospital
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel 0453707629
Email nextjim1@yokohama-cu.ac.jp

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
2021 Year 01 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 10 Month 05 Day
Last modified on
2020 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047948

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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