Unique ID issued by UMIN | UMIN000011697 |
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Receipt number | R000013678 |
Scientific Title | An open study for effectiveness of tipepidine hibenzate in children and adolescence with depression |
Date of disclosure of the study information | 2013/09/10 |
Last modified on | 2016/03/16 00:03:02 |
An open study for effectiveness of tipepidine hibenzate in children and adolescence with depression
Asverine study for depressed youth
An open study for effectiveness of tipepidine hibenzate in children and adolescence with depression
Asverine study for depressed youth
Japan |
Depression
Psychosomatic Internal Medicine | Pediatrics | Psychiatry |
Others
NO
Safety and Efficacy of tipepidine hibenzate in depressed youth
Safety,Efficacy
Depression scale
(SDS, Birelson)
Clincal global impression
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Oral tipepidine hibenzate intake
10 | years-old | <= |
18 | years-old | >= |
Male and Female
1) Have a clincal diagnosis of depression confirmed according to ICD-10 criteria.
2)Currently attending Fukui University hospital as an outpatient.
3) Must not be on medication, otherwise no oral intake of the following; antidepressants (fluoxetine, paroxetine, sertraline, escitalopram, milnacipran, duloxetine, mirtazapine), mood stabilizers (lithium, sodium valproate, carbamazepine, lamotrigine), atypical antipsychotic medication (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonaserin, paliperidone).
4) Subjects within the age range of 10 to 17 years old.
5) No changes in medication for at least 4 weeks prior to baseline visit.
6) Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.
1)Subjects who have hypersensitivity towards tipepidine hibenzate.
2) Subjects who have not yet received informed consent of the current diagnosis.
3)Subjects who have any other current ICD-10 diagnosis of the following; "Organic, including symptomatic, mental disorders", "Mental and behavioural disorders due to psychoactive substance use", "Schizophrenia, schizotypal and delusional disorders", "Behavioural syndromes associated with physiological disturbances and physical factors", "Disorders of adult personality and behavior", "Mental Retardation", "Disorders of psychological development", "Behavioural and emotional disorders with onset usually occurring in childhood and adolescence".
4) Subjects who have a physical disorder with a need of strict diet, or a diagnosis of a severe physical disorder.
5) Subjects who are receiving medication other than the above mentioned.
6) Women who are breastfeeding, pregnant, possibility of pregnancy, or have a wish of early pregnancy.
7) Subjects who have participated in other clinical studies 3 months prior to this study.
8) Subjects who are scheduled for an immediate therapeutic plan change due to unstable physical/psychological symptoms.
9) Subjects who have a history of suicide attempt within the past 1 year.
10) Subjects who, in the investigator's opinion, might not be suitable for the study.
10
1st name | |
Middle name | |
Last name | Akemi Tomoda |
University of Fukui, Research Center for Child Mental Development
Age2 Division
Matsuoka Shimoaizuki 23-3, Eiheiji, Fukui, JAPAN 910-1193
0776-61-8677
atomoda@u-fukui.ac.jp
1st name | |
Middle name | |
Last name | Akemi Tomoda |
University of Fukui, Research Center for Child Mental Development
Age2 Division
Matsuoka Shimoaizuki 23-3, Eiheiji, Fukui, JAPAN, 910-1193
0776-61-8677
atomoda@u-fukui.ac.jp
University of Fukui, Research Center for Child Mental Development, Age2 Division
none
Self funding
NO
2013 | Year | 09 | Month | 10 | Day |
Unpublished
Completed
2013 | Year | 03 | Month | 18 | Day |
2013 | Year | 05 | Month | 01 | Day |
2016 | Year | 03 | Month | 10 | Day |
2013 | Year | 09 | Month | 10 | Day |
2016 | Year | 03 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013678
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