UMIN-CTR Clinical Trial

Basic information
Public title	A study on the pathophysiology of psychiatric disorders using the test of opened-eye movements.
Acronym	Psychiatric disorders and eye movements
Scientific Title	A study on the pathophysiology of psychiatric disorders using the test of opened-eye movements.
Scientific Title:Acronym	Psychiatric disorders and eye movements
Region	Japan

Condition
Condition	Psychiatric disorders
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The study aims to confirm an usefulness of the exploratory eye movements test on the diagnosis of psychiatric disorders.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The outcome, accordance with clinical diagnosis, will be assessed at the completion of the designed protocol.
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	16 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with psychiatric disorders, such as schizophrenia, mood disorders, anxiety disorders, eating disorders, personality disorders and dementia, and healthy control.
Key exclusion criteria	Non.
Target sample size	450

Research contact person
Name of lead principal investigator	1st name Akeo Middle name Last name Kurumaji
Organization	Tokyo Medical and Dental University
Division name	Section of psychiatry and behavioral sciences
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5242
Email	0724.psyc@tmd.ac.jp

Public contact
Name of contact person	1st name Akep Middle name Last name Kurumaji
Organization	Tokyo Medical and Dental University
Division name	ection of psychiatry and behavioral sciences
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5242
Homepage URL
Email	0724.psyc@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental 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	Ethical Review Committee (Medical)
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel	03-3813-6111
Email	info.bec@tmd.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	2016 Year 02 Month 16 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	211
Results	Nothing particular.
Results date posted	2019 Year 08 Month 24 Day
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	Terminated
Date of protocol fixation	2016 Year 02 Month 15 Day
Date of IRB	2016 Year 02 Month 15 Day
Anticipated trial start date	2016 Year 02 Month 16 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information	The study was terminated.

Management information
Registered date	2016 Year 02 Month 15 Day
Last modified on	2019 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024271