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: 17/07/2024
• 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) Taking anti-inflammatory medications, which cannot be discontinued from one month prior to study drug administration (Visit 1) until Visit 2 or the end of the study
(7) Has a family history of male breast cancer
(8) Patients with a serious medical condition
(9) Have a drug allergy, food allergy, or a specific constitution
(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(s).

Related Information

• Primary Sponsor: Yamasue Hidenori