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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014655
Receipt No. R000017049
Scientific Title Functional magnetic resonance imaging (fMRI) study of children and adolescents with reactive attachment disorder (RAD)
Date of disclosure of the study information 2014/07/26
Last modified on 2018/07/30

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Basic information
Public title Functional magnetic resonance imaging (fMRI) study of children and adolescents with reactive attachment disorder (RAD)
Acronym fMRI study of RAD
Scientific Title Functional magnetic resonance imaging (fMRI) study of children and adolescents with reactive attachment disorder (RAD)
Scientific Title:Acronym fMRI study of RAD
Region
Japan

Condition
Condition Reactive Attachment Disorder
Classification by specialty
Pediatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate brain activation with fMRI during a cognitive task of children and adolescents with reactive attachment disorder (RAD).
Basic objectives2 Others
Basic objectives -Others To detect the neurobiological substrates in RAD.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes fMRI analysis: brain function with fMRI during a cognitive task.
Key secondary outcomes Neuropsychological test

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Patients with RAD
Interventions/Control_2 Normal controls
Interventions/Control_3 Patients with ADHD
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
7 years-old <=
Age-upper limit
18 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 7-18 years old.
3) Must demonstrate an acceptable
degree of compliance with medication and procedures in the opinion of the investigator.
Key exclusion criteria 1) 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".
2) Subjects who have a diagnosis of a severe physical disorder.
3) Subjects who are planned for an
immediate therapeutic plan change due to
unstable physical or psychological symptoms.
4) Subjects with metalic device in their body.
5) Subjects who, in the Investigator's opinion,
might not be suitable for the study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akemi Tomoda
Organization University of Fukui, Research Center for Child Mental Development
Division name Division of Psychosocial Support for Nurturing
Zip code
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
Middle name
Last name Akemi Tomoda
Organization University of Fukui, Research Center for Child Mental Development
Division name Division of Psychosocial Support for Nurturing
Zip code
Address 23-3, Matsuokashimoaizuki, Eiheiji, Fukui, Japan 910-1193
TEL 0776-61-8677
Homepage URL http://www.med.u-fukui.ac.jp/cdrc/welcome.html
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 : Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology (MEXT) of Japan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Aichi Children's Health and Medical Center
National Institute for Physiological Sciences
RIKEN Center for Life Science Technologies
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 福井大学子どものこころの発達研究センター

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 26 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
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 Open public recruiting
Date of protocol fixation
2012 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 26 Day
Last modified on
2018 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017049

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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