UMIN-CTR Clinical Trial

Basic information
Public title	Measurement of AMPA receptor density in persons with ARMS: a PET study
Acronym	AMPA PET study in persons with ARMS
Scientific Title	Assessment of AMPA receptor density in persons with ARMS: a cross-sectional [11C]K-2 PET study
Scientific Title:Acronym	AMPA PET study in persons with ARMS
Region	Japan

Condition
Condition	At risk mental state (ARMS)
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure AMPA receptor densities in persons with ARMS and characterize AMPA receptor density among those who subsequently develop to psychosis in comparison to those who do not
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	AMPA receptor densities measured at the 1st [11C]K-2 PET scan in persons with ARMS who subsequently develop to psychosis during a 2-year follow-up period and those who do not
Key secondary outcomes	Association between the AMPA receptor densities measured at the 1st [11C]K-2 PET scan and the duration between the time of the scan and the onset of psychosis in persons with ARMS who develop to psychosis Association between %change in the AMPA receptor densities and %change in symptomatology scales between the 2nd and 1st scans Adverse events during 7 days after administration of [11C]K-2

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Radiopharmaceutical [11C] K-2 is administered once, intravenously at 370 MBq for 1 minute. For those who develop psychosis during the follow-up period, the same intervention will be performed to measure AMPA receptor density.
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	16 years-old <=
Age-upper limit	39 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Fulfilling the criteria of at risk mental state according to SIPS (Structured Interview for Prodromal Syndromes)/SOPS(The Scale of Prodromal Symptoms) (2) For those aged 20 or older, being capable of providing informed consent; For those aged under 20, being capable of providing written informed consent as well as the written approval of study participation by their guardians
Key exclusion criteria	(1) being pregnant or breast-feeding, or wishing to become pregnant, (2) being sensitive to alcohol, (3) comorbidity of serious neurological illness, (4) history of epilepsy, (5) use of perampanel or topiramate within 4 weeks, (6) history of substance use disorder for the past 6 months, (7) positive result on urine screening of substances that cause dependence, (8) having a metal object or pace maker in the body, (9) inappropriate size of head, neck, or body for MRI scan, (10) having large tatoo, (11) suffering from serious claustrophobia, (12) presence of significant brain anomaly, (13) abnormal lab results as follows: serum creatinine level of >=1.5, AST of >=150, or ALT of >=150, (14) having participated in any clinical trial that included the use of unapproved nuclear test within 6 months, (15) having participated in any other clinical trial that included intervention, (16) being judged to be inappropriate for participation by a study medical doctor
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tomoyuki Middle name Last name Miyazaki
Organization	Yokohama City University Hospital
Division name	Anesthesiology
Zip code	236-0004
Address	3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,J apan
TEL	045-787-2579
Email	johney4@hotmail.com

Public contact
Name of contact person	1st name Tsuyoshi Middle name Last name Eiro
Organization	Yokohama City University, School of Medicie
Division name	Physiology
Zip code	236-0004
Address	3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,Japan
TEL	045-787-2579
Homepage URL
Email	eirotuyosi@gmail.com

Sponsor
Institute	Department of Physiology,Yokohama City University, School of Medicie
Institute
Department

Funding Source
Organization	japan agency for medical research and development Strategic Research Program for Brain Science,Takeda Science Foundation,Yokohama City University Hospital advanded medical
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Keio University Hospital,Kyusyu University Hospital,Fukui University Hospital,Toho University Omori Medical Center
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,Japan
Tel	045-370-7627
Email	ycu_crb@yokohama-cu.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs031190151
Org. issuing International ID_1	Japan Registry of Clinical Trials
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）、九州大学病院（福岡県）、福井大学病院（福井県）東邦大学医療センター大森病院（東京都）

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 01 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	Terminated
Date of protocol fixation	2019 Year 10 Month 28 Day
Date of IRB	2019 Year 10 Month 28 Day
Anticipated trial start date	2019 Year 10 Month 28 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry	2025 Year 03 Month 31 Day
Date trial data considered complete	2025 Year 08 Month 31 Day
Date analysis concluded	2025 Year 10 Month 31 Day

Other
Other related information	Because this study is described in the jRCT.

Management information
Registered date	2020 Year 02 Month 01 Day
Last modified on	2020 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044770