Skip to content

The clinical pilot study to examine the distribution of [11C]K-2 in depression, bipolar disease, schizophrenia, addiction,ASD,epilepsy and FTD patients in oreder to develope the novel diagnostic method in cross-sectional way toward these diseases

The clinical pilot study to examine the distribution of [11C]K-2 in depression, bipolar disease, schizophrenia, addiction,ASD,epilepsy and FTD patients in oreder to develope the novel diagnostic method in cross-sectional way toward these diseases - The clinical trial to examine the distribution of [11C]K-2 in psychiatric patients and healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025132
Enrollment
110
Registered
2016-12-02
Start date
2016-11-20
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

depression, bipolar disease, schizophrenia, alchol addict, drug addict, gambling addict, ASD,epilepsy,FTD patients and healthy volunteers

Interventions

Sponsors

Yokohama City University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1.Subjects who meet one of the following criteria 1> Being diagnosed with schizophrenia, depression or bipolar disorder by using Structured Clinical Interview for DSM-IV (SCID-I/DSM-IV), Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5) and ICD-10 2> Being diagnosed with alcohol dependence by using SCID-I/DSM-IV and ICD-10 or alcohol use disorder by using DSM5 3> Being diagnosed with amphetamine dependence by using SCID-I/DSM-IV and ICD-10 or amphetamine use disorder by using DSM5 4> Being diagnosed with pathological gambling by using DSM-IV and ICD-10 or gamble disorder by using DSM5 5> Being diagnosed with ASD by using DSM5 6> Being diagnosed with epilepsy by using ICD-10 and ILAE definition 7> Being diagnosed with Pick disease type dementia by using ICD-10, FTD by DSM5 and criteria for bvFTD 8> Healthy subjects who have never met diagnostic criteria for any psychiatric disorders by using SCID-I/DSM-IV, DSM5, or ICD-10 9> Older healthy subjects who meet 1), 2) and 3) 1)Having never met diagnostic criteria for any psychiatric disorders by using SCID-I/DSM-IV, DSM5, or ICD-10 2) A MMSE score of 24 or more 3) A Clinical Dementia Rating (CDR) score of 0 and a memory score of 0 2. 1> Males who are 30-49 years old in case of 1>, 2>, 3>, 4>, 5>, 6>, or 8> above Males who are 50-79 years old in case of 7> or 9> 3. Being capable of providing consent

Exclusion criteria

Exclusion criteria: 1. Subjects who undergo hemodialysis 2. Subjects who suffer from severe liver dysfunction 3. Subjects who suffer from neurological disorders except for neurodegenerative diseases and stroke 4. Subjects who have history of epilepsy (expect for 5> above) 5. Subjects who are taking Perampanel 6. Subjects who have had a history of substance abuse 7. Subjects who are positive in a urine screening test for addictive substances 8. Subjects who have used addictive substances fro the past 2 weeks (2> and 3> above) 9. Subjects who have experienced any of the following neuromodulation therapies: r-TMS, DBS, t-DCS, and MST 10. Subjects who have metals or a pacemaker inside their body 11.Subjects who have large head, neck or body so that they do not fit an MRI scanner 12.Subjects who have tattoos 13. Being claustrophobic 14. Subjects who have significant abnormalities in the brain 15. Subjects who shoe any of the following lab results - A serum creatinine level of 1.5mg/dL or higher - AST of 100IU/L or higher - ALT of 100IU/L or higher 16. Subjects who have undergone any examination with unapproved nuclear medicine in clinical trials for the past six months before this registration 17.Subjects who have participated in other clinical trials for the past 12 weeks before this registration 18. Study doctors consider their participation inappropriate In case that subjects who meet the Inclusion criteria 7) or 9), consider 19), 20) and 21) as well. 19. Subjects who have a previous history of schizophrenia, alcohol use disorder, amphetamine use disorder, gambling disorder, epilepsy, or ASD for their lifetime or major depressive episode or manic episode for one previous year. 20. Subject who suffer from neurodegenerative diseases, normal pressure hydrocephalus, or demyelinating diseases 21. A GDS score of 5 or more

Design outcomes

Primary

MeasureTime frame
Average values of [11C]K-2 in each disease and healthy subjects

Secondary

MeasureTime frame
The adverse events occured in patients and healthy subjects during 7days after PET scan

Countries

Japan

Contacts

Public Contactsano akane sano

Yokohama City University, School of Medicine Department of Physiology

akane@med.yokohama-cu.ac.jp045-787-2579

Outcome results

None listed

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