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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005469
Receipt No. R000006486
Scientific Title A PET study of serotonin transporter, activated microglia and energy metabolism measerment of the brain in Chronic Fatigue Syndrome.
Date of disclosure of the study information 2011/04/20
Last modified on 2016/04/20

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Basic information
Public title A PET study of serotonin transporter, activated microglia and energy metabolism measerment of the brain in Chronic Fatigue Syndrome.
Acronym A PET study of serotonin transporter, activated microglia and energy metabolism of the brain in Chronic Fatigue Syndrome.
Scientific Title A PET study of serotonin transporter, activated microglia and energy metabolism measerment of the brain in Chronic Fatigue Syndrome.
Scientific Title:Acronym A PET study of serotonin transporter, activated microglia and energy metabolism of the brain in Chronic Fatigue Syndrome.
Region
Japan

Condition
Condition Chronic Fatigue Syndrome
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To visualize and mesure serotonin transporter, microglial activation and glucose uptake among patients with Chronic Fatigue Syndrome and age matched normal controls.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Binding potential of DASB or PK11195 by PET
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 2
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 DASB, PK11195, FDG
PET
Interventions/Control_2 DASB, PK11195, FDG
PET
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
65 years-old >=
Gender Male and Female
Key inclusion criteria Patients with Chronic fatigue syndrome diagnosed in Osaka City University Hospital and healthy indivisuals, who give imformed consent
Key exclusion criteria Participants
1) with past or current history of serious medical illness and/or brain organic disease
2) with pregnancy women
3) who take central nerve system acting drugs, such as autonomic drugs and antidepressants
4) who is contradicated for the use of MRI
5) who are judged as not suitable for participation in this study
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Inaba Masaaki
Organization Osaka City University Graduated School of Medicine
Division name Metabolism, Endocrinology and Molecular Medicine
Zip code
Address 1-4-3 Asahimichi, Abeno-ku, Osaka. 543-0027
TEL 06-6645-3805
Email m1356849@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhito Nakatomi
Organization Osaka City University Graduated School of Medicine
Division name Metabolism, Endocrinology and Molecular Medicine
Zip code
Address 1-5-7 Asahimichi, Abeno-ku, Osaka. 543-0027
TEL 06-6646-3033
Homepage URL
Email nakatomi@med.osaka-cu.ac.jp

Sponsor
Institute Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduated School of Medicine
Institute
Department

Funding Source
Organization The Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Grant-in-Aid for young scientist (B)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大阪市立大学医学部附属病院(大阪), Osaka City University Hospital (Osaka)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 20 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
2009 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 04 Month 20 Day
Last modified on
2016 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006486

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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