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Investigation of microglial involvement in the effects of intranasal oxytocin on social behavior: a placebo-controlled, double-blind, crossover trial in healthy subjects.

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

Yamasue Hidenori

Hamamatsu University School of Medicine

1-20-1 Handayama Chuo-ku Hamamatsu Shizuoka

yamasue@hama-med.ac.jp

Kameno Yosuke

Hamamatsu University School of Medicine

1-20-1 Handayama Chuo-ku Hamamatsu Shizuoka

+81-80-2529-7767

oxt_trial@hama-med.ac.jp

Recruiting

April. 18, 2024

Interventional

randomized controlled trial

double blind

placebo control

crossover assignment

other

(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

(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).

Male

none

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.

PET measurement: Binding potential (BP)ND of [11C]DPA713

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.

+81-53-435-2680

April. 12, 2024

No

none