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 2023/10/15 16:46:00

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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 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

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

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.


Management information

Registered date

2017 Year 04 Month 09 Day

Last modified on

2023 Year 10 Month 15 Day



Link to view the page

Value
https://center6.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