UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011697
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

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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



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



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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013678


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name