UMIN-CTR Clinical Trial

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
Email	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
Email	takahata.keisuke@qst.go.jp

Sponsor
Institute	Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Institutes for Quantum Science and Technology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052227