JRCT ID: jRCTs031190151
Registered date:02/12/2019
A clinical trial to investigate the relationship between [11C] K-2 and the presence or absence of onset after chronic observation of psychotic high risk cases
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | ARMS |
Date of first enrollment | 28/10/2020 |
Target sample size | 30 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Administration unapproved drug |
Outcome(s)
Primary Outcome | AMPA receptor density in the brain obtained from the first PET imaging of subjects who did and did not develop psychosis during the follow-up period |
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Secondary Outcome | 1) Correlation between the AMPA receptor density in the brain and the time to onset of the examinee who developed psychosis during the follow-up period. 2) The rate of change in AMPA receptor density in the brain obtained from the first and second PET imaging in subjects who develop psychosis during the follow-up period,and correlation with the rate of change of each symptom rating scale from the PET imaging to the onset of psychosis. 3) Adverse events up to 7 days after [11C] K-2 administration. |
Key inclusion & exclusion criteria
Age minimum | >= 16age old |
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Age maximum | < 40age old |
Gender | Both |
Include criteria | We will target cases that meet all the following conditions. 1 High risk cases of psychosis that meet criteria using SIPS (Structured Interview for Prodrome Syndromes) / SOPS (The Scale of Prodromism Symptoms) 2 Men and women between 16 and 40 years old at registration 3 Patients over 20 years of age who gave written informed consent to participate in this study; under 20 years of age, informed consent was obtained for involved in this research from himself / her parents Case 4 Patients in which the patient's consent judgment ability is judged to be sufficient by the evaluation by the MacArthur Competence Assessment Tool (MacCAT) |
Exclude criteria | It will be excluded if any of the following conditions apply. 1 During pregnancy, nursing or wishing to be pregnant(For premenopausal women,blood hCG is measured by blood sampling and confirmed to be less than 6 mIU / ml) 2 Sensitive to alcohol 3 Combination of serious neurologic diseases (neurodegenerative diseases, cases of cerebral hemorrhage and cerebral infarction which are not slight in the image before this study participation) 4 History of epilepsy 5 Take Perranpanel, Topiramate, antipsychotic medication within 4 weeks before registration 6 Substance-related disorders within 6 months (except for nicotine and caffeine) 7 Dependent substances positive by urine screening (except those who are positive for the medicine being taken for treatment) 8 Implantation of metal substances and pacemakers 9 head, neck and body size not suitable for MRI scanner 10 A tattoo larger than one point (including tattoo and art makeup) 11 Advanced claustrophobic 12 A remarkable variant of brain structure (including congenital and traumatic) 13 At the time of registration, any of the following laboratory test value abnormalities Serum creatinine 1.5 mg / dl or more AST 150 IU / L or more ALT 150 IU / L or more 14 Participating in unapproved nuclear medicine clinical trials and clinical trials within 6 months prior to enrollment 15 Participating in other trials or clinical trials within 12 weeks prior to enrollment (limited to those with invasiveness / intervention) 16 Patients judged as inappropriate for study by the research investigator |
Related Information
Primary Sponsor | Eiro Tsuyoshi |
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Secondary Sponsor | Takahashi Takuya |
Source(s) of Monetary Support | Strategic Research Program for Brain Science,Takeda Science Foundation,Support by promoting advanced medical care at Yokohama City University Hospital,Japan Society for the Promotion of Science |
Secondary ID(s) |
Contact
Public contact | |
Name | Tsuyoshi Eiro |
Address | 3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,Japan Kanagawa Japan 236-0004 |
Telephone | +81-45-787-2579 |
eirotuyosi@gmail.com | |
Affiliation | Yokohama City University, School of Medicine |
Scientific contact | |
Name | Tsuyoshi Eiro |
Address | 3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,Japan Kanagawa Japan 236-0004 |
Telephone | +81-45-787-2579 |
t196014a@yokohama-cu.ac.jp | |
Affiliation | Yokohama City University Hospital |