UMIN-CTR Clinical Trial

Basic information
Public title	A research of efficacy and safety of oxytocin treatment in children and adolescents with reactive attachment disorder using functional magnetic resonance imaging (fMRI).
Acronym	Oxytocin treatment and fMRI study for RAD.
Scientific Title	A research of efficacy and safety of oxytocin treatment in children and adolescents with reactive attachment disorder using functional magnetic resonance imaging (fMRI).
Scientific Title:Acronym	Oxytocin treatment and fMRI study for RAD.
Region	Japan

Condition
Condition	Reactive Attachment 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 fMRI.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	fMRI analysis : Comparison of brain activity change after oxytocin or placebo administration.
Key secondary outcomes	plasma 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	8 years-old <=
Age-upper limit	17 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients with reactive attachment disorder based on the classifications in the diagnostic and statistical manual of mental disorders (DSM-IV-TR). Healthy children and adolescents with higher level of IQ 80. 2) Subjects within the age range of 8-17 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) Subjects who have any other current DSM-IV-TR diagnosis of the following; "Pervasive development disorder", "Attention-deficit/hyperactivity disorder","Schizophrenia and Other Psychotic Disorders","Delirium, Dementia, and Amnestic and Other Cognitive Disorders", "Substance-Related Disorders","eating disorders","personality disorders". 3) Subjects who have a physical disorder with a need of strict diet, or a diagnosis of a severe physical disorder. 4) Women who are breastfeeding, pregnant, possibility of pregnancy, or have a wish of early pregnancy. 5) Subjects who are planned for an immediate therapeutic plan change due to unstable physical or psychological symptoms. 6) Subjects with metalic device in their body. 7) Subjects who, in the Investigator's opinion, might not be suitable for the study.
Target sample size	60

Research contact person
Last 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
1st 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	Japan Society for the promotion of science
Organization
Division
Category of Funding Organization	Other
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	2014 Year 02 Month 21 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	55
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	2013 Year 05 Month 22 Day
Date of IRB	2013 Year 07 Month 02 Day
Anticipated trial start date	2013 Year 08 Month 01 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	2014 Year 02 Month 21 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=R000015419