UMIN-CTR Clinical Trial

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

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

Objectives
Narrative objectives1	Evaluating structural and functional abnormalities in white matter in patients with panic disorder compared with healthy control subjects.
Basic objectives2	Others
Basic objectives -Others	Evaluating associations between structural and functional white matter abnormalities and clinical measures in patients with panic disorder.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Structural and functional abnormalities in white matter in patients with panic disorder
Key secondary outcomes	Associations between structural and functional white matter abnormalities and clinical measures 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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	MRI data (diffusion tensor image and resisting state functional MRI) will be obtained from patients with panic disorder and healthy control subjects at once. Then, white matter structure will be compared between the two groups.
Interventions/Control_2	MRI data (diffusion tensor image and resisting state functional MRI) will be obtained from patients with panic disorder and healthy control subjects at once. Then, white matter function will be compared between the two groups.
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	1. patients with panic disorder or healthy control subjects 2. no history of loss of consciousness due to brain trauma 3. no history of dependent disorders 4. no history of physical disorders influencing brain function 5. subjects who can understand and write their agreement for this study 6. IQ above 70 7. right-handed 8. subjects who can receive MRI study
Key exclusion criteria	1. subjects who have metal in their body 2. pregnancy 3. IQ under 70 4. patients with other psychiatric disorder except for past history of depression 5. subjects judged not to be adequate for this study
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	Psychiatry
Zip code	2360004
Address	3-9, Fukuura, Kanazxawa-ku, Yokohama
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	Psychiatry
Zip code	2360004
Address	3-9, Fukuura, Kanazxawa-ku, Yokohama
TEL	0457872667
Homepage URL
Email	t_asami@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Yokohama City University
Address	3-9, Fukuura, Kanazxawa-ku, Yokohama
Tel	0457872667
Email	t_asami@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 02 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	Enrolling by invitation
Date of protocol fixation	2021 Year 02 Month 01 Day
Date of IRB	2021 Year 01 Month 12 Day
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2026 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 11 Month 08 Day
Last modified on	2022 Year 05 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048377