UMIN-CTR Clinical Trial

Basic information
Public title	The clinical pilot study to examine the distribution of [11C]K-2 in depression, bipolar disease, schizophrenia, addiction,ASD,epilepsy and FTD patients in oreder to develope the novel diagnostic method in cross-sectional way toward these diseases
Acronym	The clinical trial to examine the distribution of [11C]K-2 in psychiatric patients and healthy volunteers
Scientific Title	The clinical pilot study to examine the distribution of [11C]K-2 in depression, bipolar disease, schizophrenia, addiction,ASD,epilepsy and FTD patients in oreder to develope the novel diagnostic method in cross-sectional way toward these diseases
Scientific Title:Acronym	The clinical trial to examine the distribution of [11C]K-2 in psychiatric patients and healthy volunteers
Region	Japan

Condition
Condition	depression, bipolar disease, schizophrenia, alchol addict, drug addict, gambling addict, ASD,epilepsy,FTD patients and healthy volunteers
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the specific brain regions where there are the differences in the accumulation of [11C]K-2 between each disease and healthy subjects
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Average values of [11C]K-2 in each disease and healthy subjects
Key secondary outcomes	The adverse events occured in patients and healthy subjects during 7days after PET scan

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	The administration of PET tracer
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	30 years-old <=
Age-upper limit	80 years-old >
Gender	Male
Key inclusion criteria	1.Subjects who meet one of the following criteria 1> Being diagnosed with schizophrenia, depression or bipolar disorder by using Structured Clinical Interview for DSM-IV (SCID-I/DSM-IV), Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5) and ICD-10 2> Being diagnosed with alcohol dependence by using SCID-I/DSM-IV and ICD-10 or alcohol use disorder by using DSM5 3> Being diagnosed with amphetamine dependence by using SCID-I/DSM-IV and ICD-10 or amphetamine use disorder by using DSM5 4> Being diagnosed with pathological gambling by using DSM-IV and ICD-10 or gamble disorder by using DSM5 5> Being diagnosed with ASD by using DSM5 6> Being diagnosed with epilepsy by using ICD-10 and ILAE definition 7> Being diagnosed with Pick disease type dementia by using ICD-10, FTD by DSM5 and criteria for bvFTD 8> Healthy subjects who have never met diagnostic criteria for any psychiatric disorders by using SCID-I/DSM-IV, DSM5, or ICD-10 9> Older healthy subjects who meet 1), 2) and 3) 1)Having never met diagnostic criteria for any psychiatric disorders by using SCID-I/DSM-IV, DSM5, or ICD-10 2) A MMSE score of 24 or more 3) A Clinical Dementia Rating (CDR) score of 0 and a memory score of 0 2. 1> Males who are 30-49 years old in case of 1>, 2>, 3>, 4>, 5>, 6>, or 8> above Males who are 50-79 years old in case of 7> or 9> 3. Being capable of providing consent
Key exclusion criteria	1. Subjects who undergo hemodialysis 2. Subjects who suffer from severe liver dysfunction 3. Subjects who suffer from neurological disorders except for neurodegenerative diseases and stroke 4. Subjects who have history of epilepsy (expect for 5> above) 5. Subjects who are taking Perampanel 6. Subjects who have had a history of substance abuse 7. Subjects who are positive in a urine screening test for addictive substances 8. Subjects who have used addictive substances fro the past 2 weeks (2> and 3> above) 9. Subjects who have experienced any of the following neuromodulation therapies: r-TMS, DBS, t-DCS, and MST 10. Subjects who have metals or a pacemaker inside their body 11.Subjects who have large head, neck or body so that they do not fit an MRI scanner 12.Subjects who have tattoos 13. Being claustrophobic 14. Subjects who have significant abnormalities in the brain 15. Subjects who shoe any of the following lab results - A serum creatinine level of 1.5mg/dL or higher - AST of 100IU/L or higher - ALT of 100IU/L or higher 16. Subjects who have undergone any examination with unapproved nuclear medicine in clinical trials for the past six months before this registration 17.Subjects who have participated in other clinical trials for the past 12 weeks before this registration 18. Study doctors consider their participation inappropriate In case that subjects who meet the Inclusion criteria 7) or 9), consider 19), 20) and 21) as well. 19. Subjects who have a previous history of schizophrenia, alcohol use disorder, amphetamine use disorder, gambling disorder, epilepsy, or ASD for their lifetime or major depressive episode or manic episode for one previous year. 20. Subject who suffer from neurodegenerative diseases, normal pressure hydrocephalus, or demyelinating diseases 21. A GDS score of 5 or more
Target sample size	110

Research contact person
Name of lead principal investigator	1st name miyazaki Middle name Last name tomoyuki
Organization	Yokohama City University, School of Medicine
Division name	Department of Physiology
Zip code	045-787-2579
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2579
Email	johney@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name sano Middle name Last name akane sano
Organization	Yokohama City University, School of Medicine
Division name	Department of Physiology
Zip code	045-787-2579
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2579
Homepage URL
Email	akane@med.yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University, School of Medicine
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Certified Institutional Review Board
Address	3-9 Fukuura,kanazawa-ku,Yokohama,Kanagawa , Kanagawa
Tel	045-370-7627
Email	rinri@yokohama-cu.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	横浜市立大学附属病院（神奈川県）、慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 02 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	Completed
Date of protocol fixation	2016 Year 10 Month 04 Day
Date of IRB	2016 Year 11 Month 10 Day
Anticipated trial start date	2016 Year 11 Month 20 Day
Last follow-up date	2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 12 Month 02 Day
Last modified on	2021 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028888