The psychotropic drug dopamine PET study

JRCT ID: jRCTs031190184

Registered date:20/01/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: healthy
• Date of first enrollment: 23/01/2020
• Target sample size: 6
• Study type: Interventional

Intervention(s)

Take the 3 drugs, respectively, then PET using [18F] FE-PE2I is performed for 60 minutes from the time when the maximum blood concentration is reached after taking the drugs.
1. tramadol 100 mg
2. sertraline 50 mg
3. placebo

Outcome(s)

• Primary Outcome: the change of binding potential of dopamin transporter

Secondary Outcome

blood drug concentration
evaluation of higher brain function (neuropsychological examination)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

1) Subjects who are 20 years old or older and younger than 40 years old when obtaining consent
2) Subjects with no hisotry of psychiatric disorders
3) Subjects with normal BMI (18.5-25)
4) Subjects without the history of smoking
5) Subjects who have the ability to provide informed consent and adhere to the protocol.

Exclude criteria

1) Subjects with drug allergy
2) Subjects who have gastrointestinal symptoms when taking lactose
3) Subjects taken contraindications for the study drug within 2 weeks prior to obtaining consent
4) Subjects who is contrainidicated for the use of MRI
5) Subjects with the history of smoking, or who took cafefin (by 2 days before PET), or alcohol (by the day before PET)
6) Athletes at the competition level
7) Subjects who has been exposed to radiation by job-related exposure or therapy in one year exceeding 15mSv
8) Subjects who do not agree to notify the results of the examination which requires treatment.
9) Subjects who are judged as not suitable for participation in this study

Related Information

• Primary Sponsor: Yoshiro Okubo
• Source(s) of Monetary Support: Japan Anti-Doping Agency