NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041240017

Registered date:18/04/2024

Investigation of Serotonin 1B Receptors involvement in the effect of intranasal oxytocin on social behavior.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiednone
Date of first enrollment18/04/2024
Target sample size24
Countries of recruitment
Study typeInterventional
Intervention(s)Oxytocin will be administered intranasally to healthy subjects, [11C]AZ10419369 injection solution will be administered and a brain PET scan will be performed. In addition, assessment of social behavior will be performed to evaluate Serotonin 1B receptor involvement in the efficacy of oxytocin.

Outcome(s)

Primary OutcomePET measurement: Binding potential (BP)ND of [11C]AZ10419369
Secondary OutcomeEvaluation 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
GenderMale
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

Contact

Public contact
Name Yosuke Kameno
Address 1-20-1 Handayama Chuo-ku Hamamatsu Shizuoka Shizuoka Japan 431-3192
Telephone +81-80-2529-7767
E-mail oxt_trial@hama-med.ac.jp
Affiliation Hamamatsu University School of Medicine
Scientific contact
Name Hidenori Yamasue
Address 1-20-1 Handayama Chuo-ku Hamamatsu Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2295
E-mail yamasue@hama-med.ac.jp
Affiliation Hamamatsu University School of Medicine