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

JRCT ID: jRCTs031230715

Registered date:18/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Adverse Childhood Experiences
• Date of first enrollment: 10/06/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Administration unapproved drug

Outcome(s)

• Primary Outcome: Has 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 Outcome

1) 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
• Gender: Both

Include criteria

1) 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 attempts, no suicidal ideation or self-harm behavior 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 criteria

1) 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

• Primary Sponsor: Asami Takeshi
• Secondary Sponsor: Miyazaki Tomoyuki
• Source(s) of Monetary Support: Japan Science and Technology Agency