Unique ID issued by UMIN | UMIN000039358 |
---|---|
Receipt number | 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 14:12:36 |
Measurement of AMPA receptor density in persons with ARMS: a PET study
AMPA PET study in persons with ARMS
Assessment of AMPA receptor density in persons with ARMS: a cross-sectional [11C]K-2 PET study
AMPA PET study in persons with ARMS
Japan |
At risk mental state (ARMS)
Psychiatry | Adult |
Others
NO
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
Pharmacokinetics
Confirmatory
Explanatory
Not applicable
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
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Diagnosis
Medicine |
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.
16 | years-old | <= |
39 | years-old | >= |
Male and Female
(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
(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
30
1st name | Tomoyuki |
Middle name | |
Last name | Miyazaki |
Yokohama City University Hospital
Anesthesiology
236-0004
3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,J apan
045-787-2579
johney4@hotmail.com
1st name | Tsuyoshi |
Middle name | |
Last name | Eiro |
Yokohama City University, School of Medicie
Physiology
236-0004
3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,Japan
045-787-2579
eirotuyosi@gmail.com
Department of Physiology,Yokohama City University, School of Medicie
japan agency for medical research and development Strategic Research Program for Brain Science,Takeda Science Foundation,Yokohama City University Hospital advanded medical
Non profit foundation
Japan
Keio University Hospital,Kyusyu University Hospital,Fukui University Hospital,Toho University Omori Medical Center
Yokohama City University Certified Institutional Review Board
3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,Japan
045-370-7627
ycu_crb@yokohama-cu.ac.jp
YES
jRCTs031190151
Japan Registry of Clinical Trials
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)
2020 | Year | 02 | Month | 01 | Day |
Unpublished
Terminated
2019 | Year | 10 | Month | 28 | Day |
2019 | Year | 10 | Month | 28 | Day |
2019 | Year | 10 | Month | 28 | Day |
2025 | Year | 03 | Month | 31 | Day |
2025 | Year | 03 | Month | 31 | Day |
2025 | Year | 08 | Month | 31 | Day |
2025 | Year | 10 | Month | 31 | Day |
Because this study is described in the jRCT.
2020 | Year | 02 | Month | 01 | Day |
2020 | Year | 08 | Month | 07 | Day |
Value
https://center6.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 |