UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014655 |
|---|---|
| Receipt number | R000017049 |
| Scientific Title | Structural and functional magnetic resonance imaging (sMRI, fMRI) study of children and adolescents with reactive attachment disorder (RAD) |
| Date of disclosure of the study information | 2014/07/26 |
| Last modified on | 2024/08/01 09:18:43 |
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Basic information
Public title
Structural and functional magnetic resonance imaging (sMRI, fMRI) study of children and adolescents with reactive attachment disorder (RAD)
Acronym
MRI study of RAD
Scientific Title
Structural and functional magnetic resonance imaging (sMRI, fMRI) study of children and adolescents with reactive attachment disorder (RAD)
Scientific Title:Acronym
MRI 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 structure and function with MRI during resting state/cognitive task in 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
sMRI and fMRI analysis: brain structure and function with MRI during resting state/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 70.
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 | 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-cho Fukui, 910-1193 Japan
TEL
0776-61-8677
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-cho Fukui, 910-1193 Japan
TEL
0776-61-8677
Homepage URL
http://www.med.u-fukui.ac.jp/cdrc/welcome.html
atomoda@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui, Research Center for Child Mental Development, Division of Psychosocial Support for Nurturing
Institute
Department
Personal name
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
The Research Ethics Committee of the University of Fukui
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho Fukui, 910-1193 Japan
Tel
0776-61-3111
sm-kenkyusien@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
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
| 2013 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | 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 | 07 | Month | 26 | Day |
Last modified on
| 2024 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017049
