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

JRCT ID: jRCTs031190151

Registered date:02/12/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: ARMS
• Date of first enrollment: 28/10/2020
• Target sample size: 30
• 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

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
• 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
• 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