UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003383 |
|---|---|
| Receipt number | 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 17:25:45 |
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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
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
atojima@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004108
