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A clinical trial to examine the distribution of [11C]K-2 in patients with schizophrenia

The relationship of AMPA receptor density in patients with schizophrenia: A transversal PET study using [11C] K-2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031190197
Enrollment
30
Registered
2020-01-31
Start date
2020-02-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

Sponsors

Miyazaki Tomoyuki
Lead Sponsor
Takahashi Takuya
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: We will target cases that meet all the following conditions. 1. Psychiatric Diagnostic Interview Manual (Structured Clinical Interview for DSM-IV, SCID-I / DSM-IV), Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5), and International Disease Classification 10th Edition (International Statistical Classification) of Diseases and Related Health Problems 10th Revison, ICD-10) that meet the criteria for schizophrenia. 2. Men and women between 20 and 60 years old at the time of registration 3. Patients who have given written consent to participate in this study. 4. Those who are judged to have sufficient consent judgment ability of the person in the evaluation by MacCAT.

Exclusion criteria

Exclusion 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 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

Design outcomes

Primary

MeasureTime frame
Correlation between AMPA receptor density and PANSS score in right middle temporal gyrus and right front zonaal gyrus obtained by PET examination with [11C] K-2 in patients with schizophrenia.

Secondary

MeasureTime frame
1) Correlation between AMPA receptor density in brain and disease state image evaluated other than PANSS 2) Adverse events up to 7 days after [11C] K-2 administration.

Contacts

Public ContactTsuyoshi Eiro

Yokohama City University, School of Medicine

eirotuyosi@gmail.com+81-45-787-2579

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026