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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002654
Receipt No. 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

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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
Email

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
Email tinoue@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital, Department of Psychiatry
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003232

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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