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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031230715

Registered date:18/03/2024

Exploratory study using [11C]K-2 to identify brain regions that contribute to acquiring mental resilience based on AMPA receptor density

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedAdverse Childhood Experiences
Date of first enrollment10/06/2024
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Administration unapproved drug

Outcome(s)

Primary OutcomeHas a history of adversity/suicidal behavior, Has a history of adversity/no history of suicidal behavior, Healthy person, Differences in AMPA receptor density in the brain between the three groups
Secondary Outcome1) Has a history of adversity/suicidal behavior, Has a history of adversity/no history of suicidal behavior, Correlation between AMPA receptor density in the brain and psychological test results (HAM-D (depression), ACEs (adversity experiences), C-SSRS (suicidal tendency) for the above two groups. 2) Has a history of adversity/suicidal behavior, Has a history of adversity/no history of suicidal behavior, Correlation between brain AMPA receptor density and epigenomic results for the above two groups.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 30age old
GenderBoth
Include criteria1) Person whose aged 20 to under 30 at the time of obtaining consent 2) Person who have the ability to express a choice in the MacArthur Competence Assessment Tool (MacCAT), and written consents are provided by them 3) Person who have a history of abuse experiences under the age of 18 and are receiving treatment in a psychiatric or psychosomatic medicine department at the time of obtaining consent 4) Those without schizophrenia spectrum disorder, neurodevelopmental disorders, or anorexia nervosa in DSM-5-TR 5) Those without dependence syndrome according to ICD-10 6) Person who fall under any of the following - Suicide attempt group: Those with a history of a suicide attempt or strong suicidal ideation within the past 2 years at the time of obtaining consent. - Non-suicidal attempt group: Subjects with no history of suicide attempt or non-suicidal self-harm behavior, and no suicidal ideation within the past 2 years at the time of obtaining consent. However, suicidal ideation ('Wish to be Dead' in C-SSRS4) is distinguished from suicidal ideation.
Exclude criteria1) Pregnant, breastfeeding, or wishing to become pregnant soon (For premenopausal women, blood hCG will be tested by blood collection prior to registration and confirmed to be below 6 mIU/ml. And, request that you use contraception until one week after the PET scan.) 2) Hypersensitive to ethanol 3) Neurolog ical disease (neurodegenerative disease, minor cerebral hemorrhage or cerebral infarction) 4) History of malignant brain tumor 5) History of epilepsy 6) Taking perampanel and topiramate 7) Under medical treatment for other diseases 8) Pacemaker or any metal devices in the body 9) Head, neck and body size are not suitable for MRI scanner 10) Big tattoo and art makeup on their skin 11) Severe claustrophobia 12) Congenital or traumatic brain abnormalities 13) Any of the following abnormal laboratory test values - Serum creatinine 1.5mg / dl or more - AST 150IU/L or more - ALT 150IU/L or more 14) Person who have taken [11C] K-2 PET in other clinical trials 15) Participants with unapproved nuclear medicine tests or clinical trials within 6 months before registration 16) Participants of other clinical trials or clinical trials within 12 weeks prior to enrollment (limited to those with invasion/intervention) 17) Other reasons by the investigator

Related Information

Contact

Public contact
Name Ryo Sasaki
Address 3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,Japan Kanagawa Japan 236-0004
Telephone +81-45-787-2800
E-mail e123045g@yokohama-cu.ac.jp
Affiliation Yokohama city University Hospital
Scientific contact
Name Takeshi Asami
Address 3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,Japan Kanagawa Japan 236-0004
Telephone +81-45-787-2800
E-mail t_asami@yokohama-cu.ac.jp
Affiliation Yokohama city University Hospital