UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026914 |
|---|---|
| Receipt number | 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 | 2025/04/17 23:48:59 |
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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
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
kameno@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Soc. for the Promotion of Sci.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hamamatsu Medical Photonics Foundation
Hamamatsu Photonics K.K,
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
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
No longer 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
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
21 subjects of healthy control and 19 subjects with major depression were recruited. The recruitment is currently closed.
Management information
Registered date
| 2017 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030872
