UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042013 |
|---|---|
| Receipt number | 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 | 2024/04/09 17:39:13 |
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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
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
t_asami@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 12 | 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 | 10 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047948
