UMIN-CTR Clinical Trial

Public title

A prospective observational study on the efficacy of switching to sertraline in depressive patients who failed treatment with duloxetine

Acronym

A prospective observational study on the efficacy of switching to sertraline in depressive patients who failed treatment with duloxetine

Scientific Title

A prospective observational study on the efficacy of switching to sertraline in depressive patients who failed treatment with duloxetine

Scientific Title:Acronym

A prospective observational study on the efficacy of switching to sertraline in depressive patients who failed treatment with duloxetine

Region

Japan

Condition

major depressive disorder

Classification by specialty

Psychiatry

Adult

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

The objective of this study is to investigate the clinical response of sertraline in patients who failed treatment with duloxetine. In addition, we would like to explore the clinical, genetic, epigenetic, and metabolome factors between responders and non-responders, and between remitter and non-remitter of sertraline treatment as a possible predictors of sertraline.
This prospective observational study provides the clinical implication in switching from duloxetine to sertraline for the first time as well as detecting predictors for the response of sertraline, who failed treatment with duloxetine in patients of depression.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Efficacy rate of switching from duloxetine to sertraline using CGI-I, HAM-D, patient rating scales (CES-D)

Key secondary outcomes

Epigenetic changes before and after sertraline treatment
Baseline clinical, genetic, and epigenetic and metabolome factors in sertraline responders compared to those of non-responders
Baseline clinical, genetic, and epigenetic and metabolome factors in sertraline remitters compared to those of non-remitters

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Subjects fulfilled the DSM-IV criteria for major depressive disorder
Men and women aged 20 or over
Non-responder with duloxetine 60mg more than 6 weeks symptomatic worsening during duloxetine treatment or intolerant patients (Not achieved 50% MADRS reduction or MADRS<12)
(Baseline HAM-D or CES-D)
Subject who can understand and sign written informed consent by his/her own free will

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects fulfilled the DSM-IV criteria for major depressive disorder
Men and women aged 20 or over
Non-responder with duloxetine 60mg more than 6 weeks symptomatic worsening during duloxetine treatment or intolerant patients (not achieved 50% HAM-D reduction or HAM-D<7)
Subject who can understand and sign written informed consent by his/her own free will

Key exclusion criteria

Comorbidity of alcohol and/or drug abuse
Presence of psychosis Intolerant to sertraline Required prohibited concomitant therapy (to be described)
Pregnant women women suspected of being pregnant or breastfeeding
Serious or unstable medical illness
Judged to be at risk by the investigator

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Takahashi hitoshi

Organization

Tokyo Womens Medical University

Division name

Department of Psychiatry

Zip code

Address

8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan

TEL

0333538111

Email

takahashi.hitoshi@twmu.ac.jp

Name of contact person

1st name
Middle name
Last name	Takahashi hitoshi

Organization

Tokyo Womens Medical University

Division name

Department of Psychiatry

Zip code

Address

8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan

TEL

0333538111

Homepage URL

Email

takahashi.hitoshi@twmu.ac.jp

Institute

Tokyo Womens Medical University

Institute

Department

Personal name

Organization

Tokyo Womens Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京女子医科大学病院（東京都）　Tokyo Women’s Medical University(Tokyo)

Date of disclosure of the study information

2012

Year

12

Month

21

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

Enrolling by invitation

Date of protocol fixation

2012

Year

10

Month

23

Day

Date of IRB

Anticipated trial start date

2012

Year

12

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

All patients are treated with sertraline in a dose range from 25 mg/day to 100 mg/day after down-titration of the dose of duloxetine

Registered date

2012

Year

12

Month

21

Day

Last modified on

2017

Year

12

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011270