UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042382 |
|---|---|
| Receipt number | R000048377 |
| Scientific Title | Structural and functional white matter abnormalities in patients with panic disorder- whole brain analyses |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2022/05/12 18:34:27 |
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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
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
t_asami@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048377
