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Recruitment status Completed
Unique ID issued by UMIN UMIN000011697
Receipt No. 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

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Basic information
Public title An open study for effectiveness of tipepidine hibenzate in children and adolescence with depression
Acronym Asverine study for depressed youth
Scientific Title An open study for effectiveness of tipepidine hibenzate in children and adolescence with depression
Scientific Title:Acronym Asverine study for depressed youth
Region
Japan

Condition
Condition Depression
Classification by specialty
Psychosomatic Internal Medicine Pediatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Safety and Efficacy of tipepidine hibenzate in depressed youth
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Depression scale
(SDS, Birelson)
Clincal global impression
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral tipepidine hibenzate intake
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
10 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 10

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 Age2 Division
Zip code
Address Matsuoka Shimoaizuki 23-3, 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 Age2 Division
Zip code
Address Matsuoka Shimoaizuki 23-3, Eiheiji, Fukui, JAPAN, 910-1193
TEL 0776-61-8677
Homepage URL
Email atomoda@u-fukui.ac.jp

Sponsor
Institute University of Fukui, Research Center for Child Mental Development, Age2 Division
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 10 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 Completed
Date of protocol fixation
2013 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 01 Day
Last follow-up date
2016 Year 03 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 10 Day
Last modified on
2016 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013678


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