Investigation of microglial involvement in the effect of intranasal oxytocin on social behavior.

JRCT ID: jRCTs041240018

Registered date:18/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: none
• Date of first enrollment: 18/04/2024
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Oxytocin will be administered intranasally to healthy subjects, [11C]DPA713 injection solution will be administered and a brain PET scan will be performed. In addition, assessment of social behavior will be performed to evaluate microglial involvement in the efficacy of oxytocin.

Outcome(s)

• Primary Outcome: PET measurement: Binding potential (BP)ND of [11C]DPA713
• Secondary Outcome: Evaluation of social behavior: number of friend / foe judgments based on nonverbal information during Verbal Non-verbal Test (VnV) and their reaction time and gazing time on eye region.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 55age old
• Gender: Male

Include criteria

(1) Males between the ages of 18 and 55 at the time consent is obtained
(2) Total intelligence quotient > 80
(3) Individuals who have given their written consent to participate in this study

Exclude criteria

(1) Has been diagnosed with a mental illness
(2) Use of psychotropic drugs in the past 6 months
(3) History of hypersensitivity to oxytocin
(4) History of epileptic seizures or head trauma with loss of consciousness for more than 5 minutes
(5) History of alcohol-related or other substance-related disorders
(6) History of taking anti-inflammatory drugs within the past month
(7) Family history of male breast cancer
(8) Any significant medical complications
(9) Have a drug allergy, food allergy, or a specific physical condition
(10) Who cannot give consent to use contraception during the study period
(11) Participate in any other research or clinical research (except for research involving PET imaging using [11C]DPA713) and receive any medication within 120 days prior to obtaining consent
(12) Other subjects deemed ineligible for this study by the Principal Investigator.

Related Information

• Primary Sponsor: Yamasue Hidenori