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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048377


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name