UMIN-CTR Clinical Trial

Basic information
Public title	Neuroimaging and physiological studies in psychiatric disorders with cognitive and emotional dysfunction
Acronym	Neuroimaging and physiological studies in psychiatric disorders
Scientific Title	Neuroimaging and physiological studies in psychiatric disorders with cognitive and emotional dysfunction
Scientific Title:Acronym	Neuroimaging and physiological studies in psychiatric disorders
Region	Japan

Condition
Condition	psychiatric disorders with cognitive and emotional dysfunction
Classification by specialty	Psychiatry Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to clarify pathology of neuropsychiatric disorders
Basic objectives2	Others
Basic objectives -Others	to clarify pathology of neuropsychiatric disorders
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	evaluating structural and functional brain changes and associations between brain changes and physiological function
Key secondary outcomes	evaluating changes of physiological function

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Comparing structural and functional brain changes between patients with psychiatric disorders and healthy control subjects using MR images. Evaluating associations between brain changes and physiological changes.
Interventions/Control_2
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	psychiatric disorders diagnosed by diagnostic criteria
Key exclusion criteria	having past history of trauma, seizures with loss of the conscious, or abuse of drugs
Target sample size	200

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	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2667
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	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2667
Homepage URL
Email	t_asami@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Grants-in-aid for scientific research
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	The Yokohama City University Ethical Review Board
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
Tel	045-370-7627
Email	ynextedu@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	横浜市立大学附属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 14 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	Open public recruiting
Date of protocol fixation	2014 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date	2019 Year 05 Month 31 Day
Date of closure to data entry	2019 Year 05 Month 31 Day
Date trial data considered complete	2019 Year 05 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 06 Month 13 Day
Last modified on	2020 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016607