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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026914
Receipt No. R000030872
Scientific Title Clinical study of evaluated the changes of activated microglia in patients of major depressive disorder and bipolar disorder: A PET study
Date of disclosure of the study information 2017/04/10
Last modified on 2020/10/11

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Basic information
Public title Clinical study of evaluated the changes of activated microglia in patients of major depressive disorder and bipolar disorder: A PET study
Acronym Evaluation for activated microglia using PET in patients of major depressive disorder and bipolar disorder
Scientific Title Clinical study of evaluated the changes of activated microglia in patients of major depressive disorder and bipolar disorder: A PET study
Scientific Title:Acronym Evaluation for activated microglia using PET in patients of major depressive disorder and bipolar disorder
Region
Japan

Condition
Condition major depressive disorder
bipolar disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Both major depressive disorder(MDD) and bipolar disorder(BPD) are clinically characterized by episodes of depression, which causes the misdiagnosis and the incorrect treatment. Thus the elucidation of the pathophysiology of the MDD and BPD and the development of novel treatments are needed. Recently, the neuroinflammatory hypothesis is noted as one of the convincing pathophysiological hypothesis of MDD. However, it is unclear the influence of the activated microglia that play an important role of neuroinflammation.
We investigate the association between activated microglia and the hypothesis of monoamine, HPA axis and BDNF using 11C-DPA713 that is specific tracer of activated microglia, contributing to elucidate the pathophysiology of MDD and BPD.
Basic objectives2 Others
Basic objectives -Others We investigate the association between the binding potential of 11C-DPA713 and 11C-DASB and the severity of depressive symptom.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the binding potential of 11C-DPA713 and 11C-DASB in superior and anterior frontal gyrus, orbitofrontal cortex, anterior cingulate gyrus, striatum and hippocampus.
Key secondary outcomes MRI: T1WI, MRS-MEGAPRESS, rs-fMRI, DTI
Cytokine: FGF-2, Eotaxin, G-CSF, GM-CSF, IFN-r, IL-1b, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17, IP-10, MCP-1, MIP-1a, MIP-1b, PDGF-BB, RANTES, TNF-a, VEGF, TGF-b1, TGF-b2, TGF-b3
Tryptophan metabolites: DL-Tryptophan, L-5-hydroxy-tryptophan, Serotonin, L-Kynurenine, 5-Hydroxytryptophol, Tryptophol, 5-hydroxyindole-3-acetic acid, indole-3-acetic acid, Anthranilate, Kynurenic Acid, Quinolinecarboxylic Acid, Indole-3-butyric acid, 3-Hydroxykynurenine, 3-hydroxyanthranilate, xanthurenic acid
mature BDNF, proBDNF
Psychological test: BDI-II, HDRS, YMRS, IES-R, ICG, STAI, SASS, SRRS, CGI-S, WAIS-III, JART
Genetic examination: genetic polymorphism analysis and DNA methylation analysis of 5-HTT, GR, BDNF. Global DNA methylation analysis and expression analysis.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 PET:11C-DPA713(activated microglia) and 11C-DASB(serotonin transporter) 5MBq/kg i.v
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
50 years-old >
Gender Male and Female
Key inclusion criteria Health control
-Without past or current history psychiatric illness

Illnesses groups
-Diagnosed as major depressive disorder and bipolar disorder on DSM-5
Key exclusion criteria -With current history of psychiatric disorder in healthy control
-critical state such as suicide attempt
-With past or current history of neurological illness (including normal variant such as cave of septum pellucidum detected by MRI)
-With past or current history of serious medical illness and/or brain organic diseases
-taking medicines such as antiallergic, anticholinergic, antiinflammatory and immunosuppressive agents
-History of alcoholics or substance abuse or addiction
-In pregnancy or lactation
-smoking or having smoking history
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Yosuke
Middle name
Last name Kameno
Organization Hamamatsu University school of medicine
Division name psychiatry
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL 053-435-2295
Email kameno@hama-med.ac.jp

Public contact
Name of contact person
1st name Yosuke
Middle name
Last name Kameno
Organization Hamamatsu University school of medicine
Division name psychiatry
Zip code 4313192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL 053-435-2295
Homepage URL
Email kameno@hama-med.ac.jp

Sponsor
Institute Hamamatsu University school of medicine
Institute
Department

Funding Source
Organization Japan Soc. for the Promotion of Sci.
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 Hamamatsu University school of medicine
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
Tel 053-435-2111
Email rinri@hama-med.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
2017 Year 04 Month 10 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
2017 Year 04 Month 01 Day
Date of IRB
2017 Year 03 Month 31 Day
Anticipated trial start date
2018 Year 06 Month 27 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 03 Month 31 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 04 Month 09 Day
Last modified on
2020 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030872

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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