UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013215 |
|---|---|
| Receipt number | R000015419 |
| 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). |
| Date of disclosure of the study information | 2014/02/21 |
| Last modified on | 2019/03/31 23:59:56 |
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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
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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015419
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
