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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003383
Receipt No. R000004108
Scientific Title A study in the effects of sertraline on depressive symptoms of patients with inoperable advanced pancreatic cancer
Date of disclosure of the study information 2010/04/01
Last modified on 2012/10/16

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Basic information
Public title A study in the effects of sertraline on depressive symptoms of patients with inoperable advanced pancreatic cancer
Acronym A study in the effects of sertraline on depressive symptoms of patients with inoperable advanced pancreatic cancer
Scientific Title A study in the effects of sertraline on depressive symptoms of patients with inoperable advanced pancreatic cancer
Scientific Title:Acronym A study in the effects of sertraline on depressive symptoms of patients with inoperable advanced pancreatic cancer
Region
Japan

Condition
Condition Inoperable advanced pancreatic cancer
Classification by specialty
Gastroenterology Psychiatry
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We examine the effects of sertraline on depressive symptoms of patients with inoperable advanced pancreatic cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Score of HADS
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 sertraline
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
25 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who are as follows:
1) inoperable advanced pancreatic cancer
2) notification of disease name
3) prognosis of more than 3 months
4) more 25 year-old
5) positive by two-question screening tool
6)written informed consent
Key exclusion criteria The patients who are as follows:
1) use of prohibited concomitant medications
2) cerebrovascular disease and/or metastasis into central nerve system
3) mental disorders treated with psychotropics and/or with the need for therapy
4) participation unfitness to study by physicians
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Ozaki
Organization Graduate School of Medicine, Nagoya University
Division name Department of Psychiatry/Department of Psychiatry for Parents and Children
Zip code
Address 65,tsurum-cho,shouwa-ku,Nagoya
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ayano Tojima
Organization Nagoya University Hospital
Division name Pharmacy
Zip code
Address 65,tsurum-cho,shouwa-ku,Nagoya
TEL
Homepage URL
Email atojima@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2010 Year 04 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
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
2008 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 25 Day
Last modified on
2012 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004108

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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