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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016389
Receipt No. R000019036
Scientific Title A research of efficacy and safety of oxytocin administration to detect others altruism in children and adolescents with reactive attachment disorder.
Date of disclosure of the study information 2015/01/31
Last modified on 2019/03/31

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Basic information
Public title A research of efficacy and safety of oxytocin administration to detect others altruism in children and adolescents with reactive attachment disorder.
Acronym Oxytocin administration to detect others altruism for RAD.
Scientific Title A research of efficacy and safety of oxytocin administration to detect others altruism in children and adolescents with reactive attachment disorder.
Scientific Title:Acronym Oxytocin administration to detect others altruism for RAD.
Region
Japan

Condition
Condition Reactive attachment disorder
Autism-spectrum disorder
Classification by specialty
Pediatrics Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To assess the efficacy and tolerability of administration of intranasal oxytocin in children and adolescents with reactive attachment disorder using some cognitive tasks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of score of cognitive tasks change after oxytocin or placebo administration.
Key secondary outcomes salivary oxytocin concentration
oxytocin receptor gene polymorphism
neuropsychological test

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Intranasal single administration of oxytocin
Interventions/Control_2 Intranasal single administration of placebo
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
10 years-old <=
Age-upper limit
17 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with reactive attachment disorder or autism spectrum disorder based on the classifications in the diagnostic and statistical manual of mental disorders (DSM-5).
Healthy children and adolescents with higher level of IQ 80.
2) Subjects within the age range of 10-17 years old.
3) Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.
Key exclusion criteria 1. History of allergy for oxytocin.
2. Subject who haven't been informed his/her diagnosis at getting a consent.
3. Subjects who have any other current DSM-5 diagnosis of the following;
"Schizophrenia and Other
Psychotic Disorders","Delirium, Dementia, and Amnestic and Other Cognitive Disorders", "Substance-Related Disorders",
"eating disorders","personality disorders".
4.Subjects who have a physical disorder with a need of strict diet, or a diagnosis of a severe physical disorder.
5. Subject who is administrated any antipsychotic drugs except for atypical antipsychotic.
6. Women who are breastfeeding, pregnant, possibility of pregnancy, or have a wish of early pregnancy.
7. Subjects who are planned for an immediate therapeutic plan change due to unstable physical or psychological symptoms.
8. Subjects who, in the Investigator's opinion, might not be suitable for the study.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Akemi
Middle name
Last name Tomoda
Organization University of Fukui, Research Center for Child Mental Development
Division name Division of Psychosocial Support for Nurturing
Zip code 910-1193
Address 23-3, Matsuokashimoaizuki, Eiheiji, Fukui, Japan 910-1193
TEL 0776-61-8677
Email atomoda@u-fukui.ac.jp

Public contact
Name of contact person
1st name Akemi
Middle name
Last name Tomoda
Organization University of Fukui, Research Center for Child Mental Development
Division name Division of Psychosocial Support for Nurturing
Zip code 910-1193
Address 23-3, Matsuokashimoaizuki, Eiheiji, Fukui, Japan 910-1193
TEL 0776-61-8677
Homepage URL
Email atomoda@u-fukui.ac.jp

Sponsor
Institute University of Fukui, Research Center for Child Mental Development, Division of Psychosocial Support for Nurturing
Institute
Department

Funding Source
Organization The Nikkoso Foundation for Safe Society
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Research Ethics Committee, University of Fukui
Address Matsuoka Shimoaizuki 23-3, Eiheiji, Fukui, JAPAN, 910-1193
Tel 0776-61-8529
Email chiken@ml.u-fukui.ac.jp

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
2015 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 85
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 10 Month 15 Day
Date of IRB
2014 Year 10 Month 15 Day
Anticipated trial start date
2015 Year 01 Month 31 Day
Last follow-up date
2019 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 01 Month 30 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019036

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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