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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000039358
Receipt No. R000044770
Scientific Title Assessment of AMPA receptor density in persons with ARMS: a cross-sectional [11C]K-2 PET study
Date of disclosure of the study information 2020/02/01
Last modified on 2020/08/07

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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