UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016192
Receipt number R000018778
Scientific Title Investigation for the effect of duloxetine on adolescent depression; Ver. 2
Date of disclosure of the study information 2015/03/01
Last modified on 2017/06/30 17:25:00

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Basic information

Public title

Investigation for the effect of duloxetine on adolescent depression; Ver. 2

Acronym

E-DAD

Scientific Title

Investigation for the effect of duloxetine on adolescent depression; Ver. 2

Scientific Title:Acronym

E-DAD

Region

Japan


Condition

Condition

Major Depressive Disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of duloxetine on adolescent depression with QOL as an index.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Quolity of Life; SF-36v2

Key secondary outcomes

Depression; BDI-II
Anxiety; STAI
Autistic Tnedency; PARS-TR
Attention Deficit and/or Hyperactivity; ADHD-RS


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

* On;y cognitive behavioral therapy of 50 minutes.
* 1W, 4W, 6W, 8W total 4 times.

Interventions/Control_2

* Cognitive behavioral therapy of 50 min. and duloxetine.
* CBT; 1W, 4W, 6W, 8W total 4 times.
* Duloxetine; At first we will prescribe 20mg. 1 week later we will increase to 40mg. 3 week later, depending on the request of subjects, we will regulate quantity of prescription from 20mg to 60mg. We will not change of prescription for 4 weeks.

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

16 years-old <=

Age-upper limit

24 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients of Major Depressive Disorder diagnosed by both of DSM-IV-TR and DSM-5.

Key exclusion criteria

* Remitted or partial remitted patients
* Patients with sever inhibition so as not to tolerate CBT, questionnaire and structured interview
* Pregnant women
* Patients with physical disorder

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takahiko Inagaki

Organization

Shiga University of Medical Science

Division name

Department of Community Psychiatric Medicine

Zip code


Address

Seta Tsukinowa-cho, Otsu City, Shiga

TEL

077-548-2291

Email

kerosuke@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takahiko Inagaki

Organization

Shiga University of Medical Science

Division name

Department of Community Psychiatric Medicine

Zip code


Address

Seta Tsukinowa-cho, Otsu City, Shiga

TEL

077-548-2291

Homepage URL

http://com-psy.jp/

Email

kerosuke@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Shionogi & Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Japanese Red Cross Society Nagahama Hospital

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

滋賀医科大学医学部附属病院(滋賀県)、長浜赤十字病院(滋賀県)


Other administrative information

Date of disclosure of the study information

2015 Year 03 Month 01 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

discontinued

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

Terminated

Date of protocol fixation

2014 Year 07 Month 29 Day

Date of IRB


Anticipated trial start date

2015 Year 03 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete

2017 Year 03 Month 31 Day

Date analysis concluded

2017 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 01 Month 12 Day

Last modified on

2017 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018778


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name