UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005469 |
|---|---|
| Receipt number | 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 14:41:17 |
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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
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
nakatomi@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduated School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
