UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The investigation of individual and situational differences of effects of oxytocin administration on maternal responses to infant crying
Title of the study (Brief title)	The influence of oxytocin on responses to infant crying
Region	Japan

Condition
Condition	Postpartum depression
Classification by specialty	Hepato-biliary-pancreatic medicine Not applicable Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	In this study, we will investigate whether individual difference or situational difference which are assumed to interfere with emotional regulation would modify the effects of oxytocin administration on response to infant crying.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	heart rate variability during listing to infant crying
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Medicine
Interventions/Control_1	Syntocinon spray, 24UI, once
Interventions/Control_2	physiological saline solution, 24UI, once
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 years-old >
Gender	Female
Key inclusion criteria	during nurturing their infant or toddeler
Key exclusion criteria	during pregnancy or lactating
Target sample size	34

Research contact person
Name of lead principal investigator	Michio Nomura
Organization	Kyoto University
Division name	Graduate school of Education
Address	YoshidaHonMachi, Sakyoku, Kyoto-shi, Kyoto pref.
TEL	075-753-3004
Email	nomura.michio.8u@kyoto-u.ac.jp

Public contact
Name of contact person	Daiki Hiraoka
Organization	Kyoto University
Division name	Graduate school of Education
Address	YoshidaHonMachi, Sakyoku, Kyoto-shi, Kyoto pref.
TEL	075-753-3967
Homepage URL
Email	hiraoka.daiki.54r@st.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Kyoto University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 16 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 15 Day
Anticipated trial start date	2017 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 16 Day
Last modified on	2017 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033771