UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041416 |
|---|---|
| Receipt number | R000046369 |
| Scientific Title | Comparison of frontal lobe EEG at rest and during task in depressed and healthy subjects |
| Date of disclosure of the study information | 2020/08/14 |
| Last modified on | 2023/08/21 09:45:50 |
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Basic information
Public title
Comparison of frontal lobe EEG at rest and during task in depressed and healthy subjects
Acronym
Comparison of frontal lobe EEG at rest and during task in depressed and healthy subjects
Scientific Title
Comparison of frontal lobe EEG at rest and during task in depressed and healthy subjects
Scientific Title:Acronym
Comparison of frontal lobe EEG at rest and during task in depressed and healthy subjects
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the difference of depression and healthy people in right and left frontal lobe EEG utilizing simplified Electroencephalograph
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
electroencephalogram frequency pattern
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients diagnosed as depression based on DSM-5 who are 20 years old or older 2)Decisionally not impaired judged by treating physician
Key exclusion criteria
1) Patients who have difficulties in measuring EEG because of physical or psychiatric disorder
2) Patients who have comorbidities that can interfere with the measurement s of EEG; such as patients with brain tumor, stroke or epilepsy
3) Patients undergoing treatment that may have a significant impact on EEG results (e.g., taking ECT, TMS, antiepileptic drugs).
4) Patients with strong suicidal ideation
5) Patients who have comorbid psychiatric disorder other than depression
6) Those who are considered to be ineligible by the PI or investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Taishiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Keio University School of Medicine
Division name
Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes
Zip code
106-0032
Address
Roppongi Hills North Tower 7F, 6-2-31 Roppongi, minato-ku, Tokyo, Japan
TEL
03-5786-0006
tkishimoto@keio.jp
Public contact
Name of contact person
| 1st name | Taishiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Keio University School of Medicine
Division name
Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes
Zip code
160-8582
Address
Roppongi Hills North Tower 7F, 6-2-31 Roppongi, minato-ku, Tokyo, Japan
TEL
03-5786-0006
Homepage URL
tkishimoto@keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Dainippon Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University, Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2020 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study participants will wear simple electroencephalogram and record EEG for 1 minute each while their eyes opened and closed. Then participants will have interview with psychologist/psychiatrist and are assessed their depression severity using assessment scales described below. Participants will fill out self rating scale too. This measurement will take place for two to up to five times (on different days) for each participant.
The assessment scales/test are as follows: Hamilton rating scales for depression, Montgomery Asberg depression rating scale, word fluency test, N-back test, Beck depression inventory.
In addition, participants demographic characteristics such as medication, treatment history, and current clinical global impression scale-severity will be recorded from chart as well as interview to participants treating physicians.
Management information
Registered date
| 2020 | Year | 08 | Month | 14 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046369
