UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039967 |
|---|---|
| Receipt number | R000045565 |
| Scientific Title | Examination on the differences of the symptoms which should be given priority to treatment from the perspective of major depressive disorder patients vs their physicians |
| Date of disclosure of the study information | 2020/03/27 |
| Last modified on | 2024/07/05 17:01:04 |
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Basic information
Public title
Examination on the differences of the symptoms which should be given priority to treatment from the perspective of major depressive disorder patients vs their physicians
Acronym
Examination on the differences of the symptoms which should be given priority to treatment from the perspective of major depressive disorder patients vs their physicians
Scientific Title
Examination on the differences of the symptoms which should be given priority to treatment from the perspective of major depressive disorder patients vs their physicians
Scientific Title:Acronym
Examination on the differences of the symptoms which should be given priority to treatment from the perspective of major depressive disorder patients vs their physicians
Region
| Japan |
Condition
Condition
Major depressive disorder (MDD)
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the differences of the symptoms which should be given priority to treatment from the perspective of major depressive disorder patients vs their physicians, using web-based questionnaire survey.
Basic objectives2
Others
Basic objectives -Others
Web-based questionnaire survey
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
[Survey in patients]
Measurement item:38 questions
[Survey in physicians]
Measurement item: 21 questions
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[Survey in patients]
1)Patients have ever been diagnosed with depression.
2) Patients who are currently using a medication or not currently use but have been used medication to treat depression in the past 3 months.
3) Patients who are older than 19 years or younger than 66 years old.
4) Patients who showed 10 or higher score of PHQ-9 survey in their most severe MDD symptoms in the past.
[Survey in physicians]
1)Physicians should be board-certified psychiatrists or psychosomatic internal medical doctors examining more than 40 or more MDD patients per month.
2)Physicians who are currently prescribing antidepressants to more than 75 % of their MDD patients.
Key exclusion criteria
[Survey in patients]
1) Physicians who are employed by a pharmaceutical company or marketing agency.
2) Patients who show 9 or less score of PHQ-9 survey in their most severe MDD symptoms in the past.
[Survey in physicians]
1)Physicians themselves or their relatives are employed by a pharmaceutical company or marketing agency.
Target sample size
2300
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Fujikawa |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
03-3242-1256
keita.fujikawa@takeda.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Hoshino |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
03-3242-1256
Homepage URL
tatsuya.hoshino@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited.
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Lundbeck Japan K.K.
Name of secondary funder(s)
Lundbeck Japan K.K.
IRB Contact (For public release)
Organization
Research Institute of Healthcare Data Science
Address
2-5-5, Shibadaimon, Minato-ku, Tokyo, 105-0012, Japan
Tel
03-5733-5010
rihds@jmdc.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
| 2020 | Year | 03 | Month | 27 | Day |
Related information
URL releasing protocol
https://www.dovepress.com/getfile.php?fileID=73546
Publication of results
Published
Result
URL related to results and publications
https://www.dovepress.com/getfile.php?fileID=73546
Number of participants that the trial has enrolled
828
Results
Of the 2618 patients, 828 were assigned to 326 physicians. Fewer physicians than patients reported physical symptoms in the mild stage and cognitive symptoms in the severe and mild stages. Social function was deemed to be lower by physicians than by patients across all stages. Regarding treatment expectations, more physicians than patients reported "return to a normal life" in the mild and remission stages, and more patients than physicians reported "reduction of side effects" in the severe and mild stages.
Results date posted
| 2021 | Year | 10 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 09 | Month | 10 | Day |
Baseline Characteristics
[Survey in patients]
828 people to be analyzed
Gender:655 males (79%), 173 females (21%)
Disorder stage: severe symptomatic 317, mild symptomatic 311, remission 200.
[Survey in physicians]
Psychiatrists 313 (96%), psychosomatic physicians 13 (4%)
Participant flow
Patients and physicians were screened for eligibility at the beginning of the survey. The patients were classified into three disorder stages based on their current J-PHQ-9 score, as follows: remission, mild symptomatic and severe symptomatic stage. A patient within each disorder stage was randomly assigned to a physician without replacement. Participating physicians were provided the following information for up to three patients in the patient cohort.
Adverse events
Not applicable
Outcome measures
1) Perceived as current symptom (%)
-Mood symptoms
Severe: patients 98, physicians 95, n.s.
Mild: patients 86, physicians 86, n.s.
Remission: patients 48, physicians 44, n.s.
-Physical symptoms
Severe: patients 95, physicians 92, n.s.
Mild: patients 91, physicians 85, *p<0.05.
Remission: patients 53, physicians 48, n.s.
-Cognitive symptoms
Severe: patients 87, physicians 82, *p<0.05.
Mild: patients 66, physicians 54, **p<0.01.
Remission: patients 28, physicians 30, n.s.
2) FAST score (Mean (Standard deviation))
Severe: patients 39.5 (17.2), physicians 48.9 (14.7), ***p<0.001.
Mild: patients 18.8 (13.5), physicians 29.8 (15.3), ***p<0.001.
Remission: patients 5.5 (7.4), physicians 12.9 (15.9), ***p<0.001.
3) Treatment expectations (%)
-Improvement of symptoms
Severe: patients 59, physicians 65, n.s.
Mild: patients 52, physicians 44, n.s.
Remission: patients 38, physicians 25, **p<0.01.
-Reduction of side effects
Severe: patients 10, physicians 4, **p<0.01.
Mild: patients 12, physicians 5, **p<0.01.
Remission: patients 27, physicians 19, n.s.
-Return to a normal life
Severe: patients 31, physicians 31, n.s.
Mild: patients 35, physicians 51, ***p<0.001.
Remission: patients 36, physicians 57, ***p<0.001.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 14 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 14 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 21 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 31 | Day |
Other
Other related information
Examination on the differences of the symptoms which should be given priority to treatment from the perspective of major depressive disorder patients vs their physicians
Management information
Registered date
| 2020 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045565
