UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002654 |
|---|---|
| Receipt number | R000003232 |
| Scientific Title | A study of efficacy and safety of sertraline for the treatment of major depressive disorder patients, who have benn unremitted or intolerant by paroxetine or fluvoxamine |
| Date of disclosure of the study information | 2009/10/26 |
| Last modified on | 2012/01/14 18:13:36 |
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Basic information
Public title
A study of efficacy and safety of sertraline for the treatment of major depressive disorder patients, who have benn unremitted or intolerant by paroxetine or fluvoxamine
Acronym
Efficacy of sertraline for SSRI non-remitted or intolerant cases
Scientific Title
A study of efficacy and safety of sertraline for the treatment of major depressive disorder patients, who have benn unremitted or intolerant by paroxetine or fluvoxamine
Scientific Title:Acronym
Efficacy of sertraline for SSRI non-remitted or intolerant cases
Region
| Japan |
Condition
Condition
major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine a efficacy and safety of a switch to sertraline in major depresive patients, who have been unremitted or intolerant by paroxetine or fluvoxamine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
remission rate by QIDS-SRJ
Key secondary outcomes
response rate by QIDS-SRJ
response rate by HAMD
remission rate by HAMD
reduction in QIDS-SRJ scores
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
Switching from prior SSRI (fluvoxamine or paroxetine) to 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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Written informed consent by patients
2. more than 19 years old, less than 70 years old
3. Major depessive diorder by DSM-IVTR
4. unremitted or intorelant patients by paroxetine or fluvoxamine
Key exclusion criteria
1. severe physical diseases (heart, liver, kidney)
2. significant risk of suicide
3. under treatment with cognitvie-behavioral therapy of ECT
4. pregnant or breast-feeding women or women, who may be pregnant
5. organic brain disease
6. patients, whom investigaters regard as inapporopriate for subjects
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Inoue |
Organization
Hokkaido University Hospital
Division name
Psychiatry
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
TEL
011-716-1161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Inoue |
Organization
Hokkaido University Hospital
Division name
Psychiatry
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
tinoue@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital, Department of Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital, Department of Psychiatry
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
北海道大学病院（北海道）、札幌花園病院（北海道）、本田病院（北海道）、札幌鈴木病院（北海道）、石金病院（北海道）、町立八雲総合病院（北海道）、川村メンタルクリニック（北海道）、苫小牧緑ヶ丘病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 21 | Day |
Last modified on
| 2012 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003232
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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