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

Not Applicable

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

• Registration Number: JPRN-UMIN000025132
• Lead Sponsor: Yokohama City University, School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-02
• Study Completion: 2020-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 110

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average values of [11C]K-2 in each disease and healthy subjects

Secondary Outcome Measures

Name	Time	Method
The adverse events occured in patients and healthy subjects during 7days after PET scan