UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041192 |
|---|---|
| Receipt number | R000047030 |
| Scientific Title | Driving performance and brain function in patients with mood disorders |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2021/01/21 22:07:41 |
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Basic information
Public title
Driving performance and brain function in patients with mood disorders
Acronym
A study of depression, driving, and brain function
Scientific Title
Driving performance and brain function in patients with mood disorders
Scientific Title:Acronym
Driving and brain function in depression
Region
| Japan |
Condition
Condition
Mood disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the association across driving ability, brain function, and medication in patients with mood disorders
Basic objectives2
Others
Basic objectives -Others
To compare brain function and behavioral performance during a driving simulator task in depressed and remitted patients with mood disorders and healthy subjects.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify the difference in task-performance and brain function using near-infrared spectroscopy during a driving simulator task patients with mood disorders at depressed and remitted state
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
NIRS measurement of a driving simulator task/ patients with mood disorders
Interventions/Control_2
NIRS measurement of a driving simulator task/ healthy subjects
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Meet criteria of mood disorders by ICD-10
Key exclusion criteria
1) Low IQ (> 70)
2) History of unconsciousness and brain damage
3) Sever medical conditions
4) Comobidity of personality disorders
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Matsuo |
Organization
Saitama Medical University
Division name
Psychiatry
Zip code
3500495
Address
38 Morohongo, Moroyama, Iruma, Saitama
TEL
0492761214
kmatsuo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Matsuo |
Organization
Saitama Medical University
Division name
Psychiatry
Zip code
3500495
Address
38 Morohongo, Moroyama, Iruma, Saitama
TEL
049-276-1214
Homepage URL
kmatsuo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical 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
Institutional Review Board of Saitama Medical University Hospital
Address
38 Morohongo, Moroyama, Iruma, Saitama
Tel
049-276-1354
hirb@saitama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20069.01
Org. issuing International ID_1
Saitama Medical University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | 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
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 01 | 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 | 07 | Month | 22 | Day |
Last modified on
| 2021 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047030
