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 |
A research of efficacy and safety of oxytocin treatment in children and adolescents with reactive attachment disorder using functional magnetic resonance imaging (fMRI).
Oxytocin treatment and fMRI study for RAD.
A research of efficacy and safety of oxytocin treatment in children and adolescents with reactive attachment disorder using functional magnetic resonance imaging (fMRI).
Oxytocin treatment and fMRI study for RAD.
Japan |
Reactive Attachment Disorder
Pediatrics | Psychiatry |
Others
YES
To assess the efficacy and tolerability of administration of intranasal oxytocin in children and adolescents with reactive attachment disorder using fMRI.
Safety,Efficacy
fMRI analysis : Comparison of brain activity change after oxytocin or placebo administration.
plasma oxytocin concentration
oxytocin receptor gene polymorphism
neuropsychological test
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine |
Intranasal single administration of oxytocin
Intranasal single administration of placebo
8 | years-old | <= |
17 | years-old | >= |
Male and Female
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.
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.
60
1st name | Akemi |
Middle name | |
Last name | Tomoda |
University of Fukui, Research Center for Child Mental Development
Division of Psychosocial Support for Nurturing
910-1193
23-3, Matsuokashimoaizuki, Eiheiji, Fukui, Japan 910-1193
0776-61-8677
atomoda@u-fukui.ac.jp
1st name | Akemi |
Middle name | |
Last name | Tomoda |
University of Fukui, Research Center for Child Mental Development
Division of Psychosocial Support for Nurturing
910-1193
23-3, Matsuokashimoaizuki, Eiheiji, Fukui, Japan 910-1193
0776-61-8677
atomoda@u-fukui.ac.jp
University of Fukui, Research Center for Child Mental Development, Division of Psychosocial Support for Nurturing
Japan Society for the promotion of science
Other
Research Ethics Committee, University of Fukui
Matsuoka Shimoaizuki 23-3, Eiheiji, Fukui, JAPAN, 910-1193
0776-61-8529
chiken@ml.u-fukui.ac.jp
NO
2014 | Year | 02 | Month | 21 | Day |
Unpublished
55
Completed
2013 | Year | 05 | Month | 22 | Day |
2013 | Year | 07 | Month | 02 | Day |
2013 | Year | 08 | Month | 01 | Day |
2019 | Year | 03 | Month | 30 | Day |
2014 | Year | 02 | Month | 21 | Day |
2019 | Year | 03 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015419