UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Yokohama City University, School of Medicine

Institute

Department

Personal name

Organization

AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2016

Year

12

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

12

Month

02

Day

Last modified on

2021

Year

11

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028888