UMIN-CTR Clinical Trial

Public title

Web-based Survey on the Occurrence of Emotional Blunting and Treatment Needs in Japanese Patients with Major Depressive Disorder

Acronym

Web-based Survey on Emotional Blunting in Japanese Patients with Major Depressive Disorder

Scientific Title

Web-based Survey on the Occurrence of Emotional Blunting and Treatment Needs in Japanese Patients with Major Depressive Disorder

Scientific Title:Acronym

Web-based Survey on Emotional Blunting in Japanese Patients with Major Depressive Disorder

Region

Japan

Condition

Major Depressive Disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

1. To determine the occurrence ratio of emotional blunting (EB) symptoms in Japanese patients with major depressive disorder.
2. To determine the impact of EB symptoms on the daily lives of Japanese patients with MDD.
3. To identify the perceptions and treatment needs for EB in Japanese MDD patients with EB symptoms.

Basic objectives2

Others

Basic objectives -Others

From the results of a web-based survey, we will determine the occurrence ratio of Emotional Blunting that appears in patients taking antidepressants. We will also determine how EB affects their social functioning and health-related quality of life (QOL). Furthermore, we will identify MDD patients' perceptions and treatment needs for EB.

Trial characteristics_1

Others

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Occurrence ratio of Emotional Blunting (EB) in Japanese patients with major depressive disorder

Key secondary outcomes

1. The scores of Oxford Depression Questionnaire (ODQ)
2. Correlation between severity of EB (ODQ) and severity of depressive symptoms (PHQ-9: Patient Health Questionnaire-9), or anxiety symptoms (GAD-7: Generalized Anxiety Disorder-7), social functioning (WSAS: Work and Social Adjustment Scale), QOL (EQ-5D-5L)
3. Patient's perception for EB
4. Treatment need for EB

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

18

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Male and Female

Key inclusion criteria

The following subjects are eligible for the survey if they meet all of the following criteria:
(1) Aged between 18 and 59 years old (regardless of gender)
(2)Those who have been diagnosed with MDD.
(3)Those who have been taking antidepressant medication for at least three months.
(4)Those who have been visiting a hospital for more than three months.
(5)Those who can use the Internet with a personal computer, smartphone, or tablet.
(6)Those who can give consent online based on their own free will after understanding the explanation in Japanese.

Key exclusion criteria

The preliminary web-based questionnaire ask whether any of the following conditions are met, and those who meet the conditions are not eligible for the survey.
(1) Those who have been diagnosed with bipolar disorder.
(2) Those who have been diagnosed and are under treatment for serious progressive physical illnesses such as cancer and heart failure.

Target sample size

3000

Name of lead principal investigator

1st name	Keita
Middle name
Last name	Fujikawa

Organization

Takeda Pharmaceutical Company Ltd.

Division name

Japan Medical Office

Zip code

103-8668

Address

1-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo, Japan

TEL

03-3278-2111

Email

keita.fujikawa@takeda.com

Name of contact person

1st name	Tomoki
Middle name
Last name	Ohashi

Organization

Macromill Carenet, Inc.

Division name

Macromill Carenet, Inc.

Zip code

108-0075

Address

Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan

TEL

070-1399-0192

Homepage URL

Email

to_ohhashi@macromillcarenet.jp

Institute

Takeda Pharmaceutical Company Ltd.

Institute

Department

Personal name

Organization

Takeda Pharmaceutical Company Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Institute of Healthcare Data Science

Address

SumitomoShibadaimon building 12F, 5-5, Shibadaimon 2-chome, Minato-ku, Tokyo, Japan

Tel

03-5733-5010

Email

rihds@jmdc.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

2022

Year

07

Month

28

Day

URL releasing protocol

https://onlinelibrary.wiley.com/doi/10.1002/npr2.12417

Publication of results

Published

URL related to results and publications

https://onlinelibrary.wiley.com/doi/10.1002/npr2.12417

Number of participants that the trial has enrolled

3376

Results

Of 3376 patients with major depressive disorder included in this study, 67.1% of patients self-reported EB symptoms. The mean (SD) ODQ total score was 78.2 (21.5), which increased with worsening EB symptoms. There were correlations between ODQ total scores and the PHQ-9, GAD-7, WSAS, and EQ-5D-5L scores. Descriptive analyses showed that one-third of patients reporting EB symptoms did not tell their physician, with two-thirds finding these symptoms distressing and likely to affect recovery.

Results date posted

2024

Year

04

Month

18

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Of 3376 participants included, nearly half of the participants were between 50 and 59 years of age and one-third were between 40 and 49 years of age. Just over 60% of participants were employed, with 41% receiving an annual income of less than 4 million Japanese yen. Approximately 30% of participants lived alone.

Participant flow

This web-based survey was conducted by Macromill Carenet, Inc. via the monitored patient panel. The survey was conducted between July 29, 2022, and August 9, 2022. Potential participants who met the inclusion criteria were identified from the patient panel and invited to participate. In total, 3611 patients gave consent to participate, with 3376 participants included in the analysis population (235 patients were excluded because they were not taking antidepressants).

Adverse events

Not Applicable

Outcome measures

The primary outcome of this study was to measure the prevalence of EB in patients with MDD using a validated screening question. The question was: "To what extent have you had any of the following emotional experiences in the last 6 weeks?" This was qualified by the explanation: "Emotional effects and treatment vary, but may include, for example, feeling emotionally 'numbed' or 'blunted'in some way; lacking positive emotions or negative emotions; feeling detached from the world around you; or 'just not caring' about things that you used to care about." Patients who replied "mildly," "moderately," or "severely" were defined as having EB in our study.
Secondary outcomes included the correlation between EB symptoms (measured by the Oxford Depression Questionnaire [ODQ]) and scores on the Patient Health Questionnaire 9-item (PHQ-9), Generalized Anxiety Disorder 7-item (GAD-7), Work and Social Adjustment Scale (WSAS), and the EuroQol 5-Dimension 5-Levels questionnaire (EQ-5D-5L) to investigate the correlation between the degree of EB symptoms (as measured by the ODQ) and the severity of depression/anxiety, social functioning, and health-related QoL.
The survey used in this study also included six descriptive questions to explore the patients' perception of and treatment needs for EB. Exploratory outcomes included a linguistic analysis to investigate problems with daily life reported by patients with EB. Terms appearing in the free-text field of two questions were analyzed using "KH coder", a free text-mining software for text-type materials.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2022

Year

07

Month

27

Day

Date of IRB

2022

Year

07

Month

19

Day

Anticipated trial start date

2022

Year

07

Month

29

Day

Last follow-up date

2022

Year

08

Month

09

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The database used in this study will be collected by the Web-based survey system of Macromill CareNet, Inc. Ltd.

Registered date

2022

Year

07

Month

28

Day

Last modified on

2024

Year

04

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055267