UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021033 |
|---|---|
| Receipt number | R000024271 |
| Scientific Title | A study on the pathophysiology of psychiatric disorders using the test of opened-eye movements. |
| Date of disclosure of the study information | 2016/02/16 |
| Last modified on | 2019/08/24 15:23:02 |
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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
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
0724.psyc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024271
