UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A PET study of serotonin transporter, activated microglia and energy metabolism measerment of the brain in Chronic Fatigue Syndrome.
Title of the study (Brief title)	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

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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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Inaba Masaaki
Organization	Osaka City University Graduated School of Medicine
Division name	Metabolism, Endocrinology and Molecular Medicine
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	Yasuhito Nakatomi
Organization	Osaka City University Graduated School of Medicine
Division name	Metabolism, Endocrinology and Molecular Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2009 Year 09 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000006486