A clinical trial to examine the distribution of [11C]K-2 in psychiatric patients and healthy volunteers

JRCT ID: jRCTs031180052

Registered date:10/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients with depression, bipolar disorder, schizophrenia, alcohol dependence, etc.
• Date of first enrollment: 26/12/2016
• Target sample size: 110
• Study type: Interventional
• Intervention(s): Administration of unapproved drug

Outcome(s)

• Primary Outcome: Average values of [11C]K-2 in each illness group and healthy subjects

Secondary Outcome

Efficacy
1.Correlation of the density of AMPA receptors and values of clinical rating scales
2.Correlation of the density of AMPA receptors and carbonyl stress markers
Safety
Adverse events occurred for 7 days after a PET scan

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: < 80age old
• Gender: Male

Include 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

Exclude 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 (except for nicotine and caffeine) for the past 6 months (except for 2> and 3> above)
7. Subjects who are positive in a urine screening test for addictive substances (except for those taking them as therapeutic agents)
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 (repetitive Transcranial Magnetic Stimulation), DBS (Deep Brain Stimulation), ECT (Electro-convulsive therapy), NNS (Vagal Nerve Stimulation), t-DCS (transcranial Direct Current Stimulation), and MST (Magnetic Seizure Therapy)
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

Related Information

• Primary Sponsor: Miyazaki Tomoyuki
• Secondary Sponsor: takahashi takuya
• Source(s) of Monetary Support: Strategic Research Program for Brain Science
• Secondary ID(s): UMIN000025132