UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045815 |
|---|---|
| Receipt number | R000052227 |
| Scientific Title | The relationship between symptoms and monoamine oxidase-B densities in the brain of depression and organic depression: A PET study with [11C]SL25.1188 |
| Date of disclosure of the study information | 2021/10/21 |
| Last modified on | 2021/10/21 15:57:45 |
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Basic information
Public title
The relationship between symptoms and monoamine oxidase-B densities in the brain of depression and organic depression: A PET study with [11C]SL25.1188
Acronym
The relationship between symptoms and monoamine oxidase-B densities in the brain of depression and organic depression: A PET study with [11C]SL25.1188
Scientific Title
The relationship between symptoms and monoamine oxidase-B densities in the brain of depression and organic depression: A PET study with [11C]SL25.1188
Scientific Title:Acronym
The relationship between symptoms and monoamine oxidase-B densities in the brain of depression and organic depression: A PET study with [11C]SL25.1188
Region
| Japan |
Condition
Condition
Major depressive disorder, Organic depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore the associations between monoamine oxidase-B (MAO-B) densities in the brain and blood biomarkers, brain morphology and function, neurotransmission, and symptoms in depression including major depressive disorder, bipolar disorder, and organic depression.
Basic objectives2
Others
Basic objectives -Others
To measure MAO-B distribution volume in patients with major depressive disorder, bipolar disorder, and organic depression.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Monoamine oxidase B (MAO-B) distribution volume of patients with major depressive disorders, bipolar disorders, organic depression and healthy subjects.
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
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
PET with [11C]SL25.1188 and neuropsychological tests
Interventions/Control_2
PET with [11C]SL25.1188 and neuropsychological tests
Interventions/Control_3
PET with [11C]SL25.1188 and neuropsychological tests
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
I. Patients
20 y.o.<=Age patients with major depressive disorders (DSM-5), bipolar disorders (DSM-5) and organic depression (ICD-10)
II. Healthy volunteers
20 y.o.<=Age normal subjects
Key exclusion criteria
I. Patients
1. Subjects undergoing dialysis
2. Subjects with a severe physical complication
3. Subjects with metallic medical device in the body
4. Subjects with severe claustrophobia
5. Subjects who tends to suicide
6. Pregnant women
7. Subjects participating in other clinical trials
8. Subjects who donated blood within 3 months
9. Subjects with allergy to local anesthetics and anticoagulants
10. Subjects taking anticoagulants
11. Subjects taking MAO inhibitors
12. Subjects taking supplements or health foods containing curcumin
13. Subjects taking foods, supplements, or health foods 10 hours before blood sampling
14. Subjects who is considered to be inappropriate to participate in the study
II. Healthy volunteers
1. Subjects with any psychiatric disorder
2. Subjects with any organic brain disorder
3. Subjects with substance-related disorders
4. Subjects undergoing dialysis
5. Subjects with a severe physical complication
6. Subjects with metallic medical device in the body
7. Subjects with severe claustrophobia
8. Pregnant women
9. Subjects participating in other clinical trials
10. Subjects who donated blood within 3 months
11. Subjects with allergy to local anesthetics and anticoagulants
12. Subjects taking anticoagulants
13. Subjects taking MAO inhibitors
14. Subjects taking supplements or health foods containing curcumin
15. Subjects taking foods, supplements, or health foods 10 hours before blood sampling
16. Subjects who is considered to be inappropriate to participate in the study
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Takahata |
Organization
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Institutes for Quantum Science and Technology
Division name
Department of Functional Brain Imaging Research
Zip code
2638555
Address
4-9-1 Anagawa, Inage, Chiba, Chiba, Japan
TEL
0432063251
takahata.keisuke@qst.go.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Takahata |
Organization
Institute for Quantum Medical Science
Division name
Department of Functional Brain Imaging Research
Zip code
2638555
Address
4-9-1 Anagawa, Inage, Chiba, Chiba, Japan
TEL
0432063251
Homepage URL
takahata.keisuke@qst.go.jp
Sponsor or person
Institute
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Institutes for Quantum Science and Technology
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
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Institutes for Quantum Science and Technology
Address
4-9-1 Anagawa, Inage, Chiba, Chiba, Japan
Tel
81432063025
helsinki@qst.go.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
| 2021 | Year | 10 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 21 | Day |
Last modified on
| 2021 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052227
