UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023600 |
|---|---|
| Receipt number | R000027172 |
| Scientific Title | Evaluation of Depression Based on Measurement of Brain Activity Induced by Emotional Stimuli: A Study using the Depression Detection System |
| Date of disclosure of the study information | 2016/08/15 |
| Last modified on | 2016/08/12 10:38:03 |
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Basic information
Public title
Evaluation of Depression Based on Measurement of Brain Activity Induced by Emotional Stimuli: A Study using the Depression Detection System
Acronym
Evaluation of Depression Based on Measurement of Brain Activity Induced by Emotional Stimuli: A Study using the Depression Detection System
Scientific Title
Evaluation of Depression Based on Measurement of Brain Activity Induced by Emotional Stimuli: A Study using the Depression Detection System
Scientific Title:Acronym
Evaluation of Depression Based on Measurement of Brain Activity Induced by Emotional Stimuli: A Study using the Depression Detection System
Region
| Japan |
Condition
Condition
Healthy control
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the stronger reaction of patients with depression to unpleasant images than to pleasant ones, which is assumed in depressed patients, to the findings from previous MRI studies by measuring the amount of heat generated by brain activity, using the depression detection system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Determinants of depression.
2. The possibility of change caused by treatment in the amount of heat generated by brain activity.
3. Predictors before treatment for the amount of heat generated by brain activity, responding to treatment.
Key secondary outcomes
1. The relationship to near-infrared spectroscopy (NIRS) signals, whose diagnostic significance has been established.
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Individuals with depression
Interventions/Control_2
Healthy control
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who are diagnosed with major depression according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and are currently depressed (The score should be 7 or higher).
2. Patients between the ages of 20-65.
3. Patients who scored higher than 70 of estimated premorbid IQ in JART(Japanese Adult Reading Test).
Key exclusion criteria
1. Patients who have strong suicidal ideation.
2. Patients who are currently being treated for alcohol/drug abuse.
3. Patients who have serious physical illness.
4.Patients who were determined by their doctors or head researchers to be inappropriate for research subjects for other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Kaneko |
Organization
Tottori University Faculty of Medicine
Division name
Division of Neuropsychiatry, Department of Brain and Neuroscience
Zip code
Address
36-1 Nishi-cho, Yonago, Tottori
TEL
0859-38-6547
kaneko@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shenghong Pu |
Organization
Tottori University Faculty of Medicine
Division name
Division of Neuropsychiatry, Department of Brain and Neuroscience
Zip code
Address
36-1 Nishi-cho, Yonago, Tottori
TEL
0859-38-6547
Homepage URL
pshh0517@yahoo.co.jp
Sponsor or person
Institute
Tottori University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tottori University Faculty of Medicine
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
Address
Tel
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
鳥取大学医学部附属病院（鳥取県米子市）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 15 | 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
Date of protocol fixation
| 2016 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 12 | Day |
Last modified on
| 2016 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027172
