UMIN-CTR Clinical Trial

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

Major Depressive Disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

YES

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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

now_to_last@yahoo.co.jp

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

Email

now_to_last@yahoo.co.jp

Institute

Department of psychiatry

Institute

Department

Personal name

Organization

Department of psychiatry

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

ethics committee ofUOEH

Address

1-1 Iseigaoka, Yahatanishi-ku, Kitkyushu 8078555, Japan

Tel

+81-936917205

Email

now_to_last@yahoo.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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