UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation for the effect of duloxetine on adolescent depression; Ver. 2
Title of the study (Brief title)	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	Takahiko Inagaki
Organization	Shiga University of Medical Science
Division name	Department of Community Psychiatric Medicine
Address	Seta Tsukinowa-cho, Otsu City, Shiga
TEL	077-548-2291
Email	kerosuke@belle.shiga-med.ac.jp

Public contact
Name of contact person	Takahiko Inagaki
Organization	Shiga University of Medical Science
Division name	Department of Community Psychiatric Medicine
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
Institute	Shiga University of Medical Science
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 07 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	discontinued
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018778