UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of clinical biomarkers reflecting the neurological basis of depressive symptoms and their usefulness in novel therapeutic technique
Acronym	Investigation of clinical biomarkers of depressive symptoms and their usefulness
Scientific Title	Investigation of clinical biomarkers reflecting the neurological basis of depressive symptoms and their usefulness in novel therapeutic technique
Scientific Title:Acronym	Investigation of clinical biomarkers of depressive symptoms and their usefulness
Region	Japan

Condition
Condition	depressive symptoms
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Exploring clinical biomarkers useful for diagnosis and treatment of depressive symptoms.
Basic objectives2	Others
Basic objectives -Others	nothing
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Group comparison of psychological examination and brain imaging between psychiatric disorder patients with depressed symptoms and healthy comparison.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	15 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	a. or b. A. Among patients visiting or hospitalized at Gunma University Hospital who has been diagnosed as a corresponding psychiatric disorder in accordance with DSM-5 and has been informed of the disorder or a state. B. Normal people who are free from mental illness and neurological disorder in the present and past.
Key exclusion criteria	1) Under 15 years old 2) Pacemakers, claustrophobia etc. MRI equipment contraindicated 3) Merging serious physical disorders 4) Measures Inpatients 5) Emergency hospitalized patients 6) Others judged inappropriate as subjects by doctors
Target sample size	210

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name Fukuda
Organization	Gunma University Graduate School of Medicine
Division name	Department of Psychiatry and Neuroscience
Zip code	371-8511
Address	3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL	027-220-8180
Email	fukuda-psy@gunma-u.ac.jp

Public contact
Name of contact person	1st name Yuichi Middle name Last name Takei
Organization	Gunma University Graduate School of Medicine
Division name	Department of Psychiatry and Neuroscience
Zip code	371-8511
Address	3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL	027-220-8190
Homepage URL
Email	tyuichi@gunma-u.ac.jp

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	Strategic Research Program for Train science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Gunma University Hospital Clinical Research Review Board
Address	showa 3-39-22
Tel	0272207111
Email	takeiyuichi@gmail.com

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	2017 Year 04 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	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 01 Day
Date of IRB	2017 Year 03 Month 25 Day
Anticipated trial start date	2017 Year 03 Month 14 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	Nothing

Management information
Registered date	2017 Year 03 Month 06 Day
Last modified on	2021 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030241