Oxtocin administration experiment

JRCT ID: jRCTs051190107

Registered date:17/02/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy Females
• Date of first enrollment: 17/02/2020
• Target sample size: 110
• Study type: Interventional
• Intervention(s): A double-blind, placebo-controlled test of nasal oxytocin spray

Outcome(s)

• Primary Outcome: Selection rate of "Personal Performance" or "Tournament Reward" in the economic experiment to measure the competitive preferences after administration of the drug (Oxytocin or Placebo).

Secondary Outcome

1.The degree of trusting others calculated based on the "investment " and "return " in the "economic experiment to measure social preference " conducted after administration of the test drug (oxytocin nasal spray or placebo)
2. Oxytocin concentration in saliva collected before administration of the drug (Oxytocin or Placebo) and after the economic experiment to measure competitive preference
3. Testosterone concentration in saliva collected before administration of the drug (Oxytocin or Placebo) and after the economic experiment to measure competitive preference
4. Cortisol concentration in saliva collected before administration of the drug (Oxytocin or Placebo) and after the economic experiment to measure competitive preference
5. The numbers of occurrences and frequency of adverse events during the study period from the time the study subjects were included in this clinical study to that the study was discontinued or terminated
6. Background characteristics such as age, department, behavioral economic characteristics, and impressions of the economic experiments of competitive preference will be surveyed using the questionnaires.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 45age old
• Gender: Female

Include criteria

For those who meet all of the following criteria.
(1) Premenopausal healthy women
(2) more than 20 years old and less than 45 years old at the point of informed consent
(3) No serious disease under medical treatment
A healthy woman is defined as a woman who does not have any abnormality that meets the exclusion criteria and who has had a medical checkup in 2019 or 2020.To determine the eligibility criteria, it is necessary to submit the results of a medical checkup, and following items are confirmed by the docors.
Check items:
(1) AST and ALT must be below the reference value
(2) Serum creatinine is below the reference value
(3) The absence of significant edema
(4) Systolic blood pressure < 140 mgHg and diastolic blood pressure < 90 mmHg
(5) No possibility of pregnant
(6) >= Hg10.0g / dl

Exclude criteria

(1) Pregnant and breastfeeding women
(2) History of tretment with oxytocin
(3) History of head injury with more than 5minutes consciousness
(4) Drug dependence or alcohol dependence or their previous history
(5) History of water intoxication with consciousness or seizures
(6) Polydipsia (remarkably daily heavy drinking more than 2.5L per day)
(7) Renal dysfunction
(8) Any other interested person
(9)When the research investigator determines inappropriate case for the other reasons.

Related Information

• Primary Sponsor: Nakagawa Satoshi
• Secondary Sponsor: Fumio Otake,Ministry of Education, Culture, Sports, Science and Technology