UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022267 |
|---|---|
| Receipt number | R000025654 |
| Scientific Title | Randomized comparison of venlafaxine with escitalopram for selecting the antidepressant indicating better responses to serotonin-noradrenaline reuptake inhibitor(SNRI) or selective serotonin reuptake inhibitor(SSRI) for major depressive disorder(MDD) |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/10/18 17:51:37 |
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Basic information
Public title
Randomized comparison of venlafaxine with escitalopram for selecting the antidepressant indicating better responses to serotonin-noradrenaline reuptake inhibitor(SNRI) or selective serotonin reuptake inhibitor(SSRI) for major depressive disorder(MDD)
Acronym
Selecting the better antidepressant from SNRI or SSRI for MDD; SENSE-study
Scientific Title
Randomized comparison of venlafaxine with escitalopram for selecting the antidepressant indicating better responses to serotonin-noradrenaline reuptake inhibitor(SNRI) or selective serotonin reuptake inhibitor(SSRI) for major depressive disorder(MDD)
Scientific Title:Acronym
Selecting the better antidepressant from SNRI or SSRI for MDD; SENSE-study
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The improvement rate of depressive symptoms and the treatment persistence rate after 8 weeks treatment with venlafaxine (SNRI) or escitalopram (SSRI) are compared. Predicting factors better response to each antidepressant including genetic information, plasma levels of catecholamine metabolite, and serum levels of neurotrophic factors and cytokines are also explored.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
17-item Hamilton Rating Scale for Depression: HAMD17
Key secondary outcomes
Clinical Global Improvement-Severity (CGI-S)
Quick Inventory of Depressive Symptomatology (QIDS-J)
Udvalg for Kliniske Undersogelser (UKU)
Cognitive function test (COGNITRAX)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cases starting venlafaxine for MDD episode or switching to venlafaxine from other antidepressants.
Interventions/Control_2
Cases starting escitalopram for MDD episode or switching to venlafaxine from other antidepressants.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A)
Major depressive episodes were diagnosed using the Structured Clinical interview for the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)
B)
The patients who were administered any antidepressants or those with no response to adequate amount of antidepressants (except for venlafaxine and escitalopram) for 4 weeks or more in the current episode.
C)
The severity of depression was evaluated using the 17-item Hamilton Rating Scale for Depression (HAMD17). The patients whose HAMD17 scores were 15 or above were enrolled in this study.
D)
The patients who can be signed informed concent were enrolled in the present study.
Key exclusion criteria
A)
The patients who have any history of neurological diseases or other physical diseases.
B)
The patients who have comorbidities with other disorders, bipolar disorder, personality disorders, or mental retardation.
C)
The patients who have previous history of substance-related disorders, such as drug dependence or alcohol dependence.
D)
The patients who had previously treated with venlafaxine or escitalopram.
E)
The patients who their physicians consider not suited.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Hamada |
Organization
University of Occupational and Environmental Health
Division name
Department of psychiatry
Zip code
8078555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitkyushu 8078555, Japan
TEL
+81-936917253
now_to_last@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Hamada |
Organization
University of Occupational and Environmental Health
Division name
Department of psychiatry
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitkyushu 8078555, Japan
TEL
+81-936917253
Homepage URL
now_to_last@yahoo.co.jp
Sponsor or person
Institute
Department of psychiatry
Institute
Department
Personal name
Funding Source
Organization
Department of psychiatry
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
ethics committee ofUOEH
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitkyushu 8078555, Japan
Tel
+81-936917205
now_to_last@yahoo.co.jp
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 10 | Day |
Last modified on
| 2019 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025654
