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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016192
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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