UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029417 |
|---|---|
| Receipt number | R000033616 |
| Scientific Title | Longitudinal predictive validity of the DSM-5 anxious distress specifier and comorbid generalized anxiety disorder in patients with major depressive disorder. |
| Date of disclosure of the study information | 2017/10/10 |
| Last modified on | 2023/04/09 22:13:46 |
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Basic information
Public title
Longitudinal predictive validity of the DSM-5 anxious distress specifier and comorbid generalized anxiety disorder in patients with major depressive disorder.
Acronym
Anxious distress and generalized anxiety disorder in depressive patients.
Scientific Title
Longitudinal predictive validity of the DSM-5 anxious distress specifier and comorbid generalized anxiety disorder in patients with major depressive disorder.
Scientific Title:Acronym
Anxious distress and generalized anxiety disorder in depressive patients.
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the frequency of the DSM-5 anxious distress specifier and generalized anxiety disorder among patients with major depressive disorder. Furthermore, to investigate a correlation between the specifier or comorbid generarized anxiety disorder and the severity of depression.
Basic objectives2
Others
Basic objectives -Others
To examine the validity of DSM-5 anxious distress in depressive patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of the DSM-5 anxious distress specifier and generalized anxiety disorder in patients with major depressive disorder.
Key secondary outcomes
Correlation between between the specifier or comorbid generarized anxiety disorder and the severity of depression. Futhermore, the predictive validity of the specifier or cmorbid generalized anxiety disorder was longitudibnal examined for subsequent 6-month chronicity of major depressive disorder.
Base
Study type
Observational
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with major depressive disorder who diagnosed bay DSM-5 and taking the same medication during past 3 months.
Key exclusion criteria
1)Patients who contract desease affecting cognitive disfunction, for example epilepsy, alchol dependence syndrome, dementia, organic brain disease and so on. Pregnant patients. 2)Patients who are determined by researchers that the credibility of ther responses cannnot be expected.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Tempei |
| Middle name | |
| Last name | Otsubo |
Organization
Tokyo Women's Medical University Adachi Medical Center
Division name
Departement of Psychiatry
Zip code
123-8558
Address
4-33-1 Kohoku Adachi-ku Tokyo Zip 123-8558 Japan
TEL
03-3857-0111
otsubo.tempei@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Tempei |
| Middle name | |
| Last name | Otsubo |
Organization
Tokyo Women's Medical University Adachi Medical Center
Division name
Department of psychiatry
Zip code
123-8558
Address
4-33-1 Kohoku Adachi-ku Tokyo Zip 123-8558 Japan
TEL
03-3857-0111
Homepage URL
otsubo.tempei@twmu.ac.jp
Sponsor or person
Institute
JCHO Tokyo Shinjuku Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Tokyo Shinjuku Medical Center
Address
5-1 Tsukudocho Shinjuku Tokyo Japan
Tel
03-3269-8111
otsubo.tempei@twmu.ac.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
| 2017 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Int J Psychiatry Clin Pract . 2021 Nov;25(4):385-392. doi: 10.1080/13651501.2021.1907415. Epub 2021
Publication of results
Published
Result
URL related to results and publications
Int J Psychiatry Clin Pract . 2021 Nov;25(4):385-392. doi: 10.1080/13651501.2021.1907415. Epub 2021
Number of participants that the trial has enrolled
110
Results
The DSM-5 ANXD specifier was identified in 73 patients (66.4%). A univariate analysis indicated ANXD was significantly associated with younger age; unmarried status; living alone; higher QIDS total score; higher S-EPQ neuroticism score; and higher TEMPS-A cyclothymic, depressive and irritable scores. After covariate adjustment, a multivariable linear regression analysis revealed a significant association between the QIDS total score and ANXD (three different models).
Results date posted
| 2023 | Year | 04 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Objective: Anxious distress (ANXD), which is common in major depressive disorder (MDD), is associated with poor outcomes. We investigated clinical characteristics of MDD patients with the DSM-5 ANXD specifier and only mild residual symptoms without comorbid anxiety disorders in the continuation/maintenance phase.
Methods: We recruited 110 outpatients with MDD without comorbid anxiety disorders. They were interviewed; the presence of the DSM-5 ANXD specifier was assessed. They completed the Quick Inventory of Depressive Symptomatology (QIDS), the Eysenck Personality Questionnaire (S-EPQ), the Temperament Evaluation of Memphis, Pisa, Paris and San Diego-Autoquestionnaire (TEMPS-A).
Participant flow
Objective: Anxious distress (ANXD), which is common in major depressive disorder (MDD), is associated with poor outcomes. We investigated clinical characteristics of MDD patients with the DSM-5 ANXD specifier and only mild residual symptoms without comorbid anxiety disorders in the continuation/maintenance phase.
Methods: We recruited 110 outpatients with MDD without comorbid anxiety disorders. They were interviewed; the presence of the DSM-5 ANXD specifier was assessed. They completed the Quick Inventory of Depressive Symptomatology (QIDS), the Eysenck Personality Questionnaire (S-EPQ), the Temperament Evaluation of Memphis, Pisa, Paris and San Diego-Autoquestionnaire (TEMPS-A).
Adverse events
Nothing.
Outcome measures
Methods: We recruited 110 outpatients with MDD without comorbid anxiety disorders. They were interviewed; the presence of the DSM-5 ANXD specifier was assessed. They completed the Quick Inventory of Depressive Symptomatology (QIDS), the Eysenck Personality Questionnaire (S-EPQ), the Temperament Evaluation of Memphis, Pisa, Paris and San Diego-Autoquestionnaire (TEMPS-A).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
There is a few study on the correlation between the specifier and comorbid generalized anxiety disorder.
Management information
Registered date
| 2017 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033616
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