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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029417
Receipt No. 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 2017/10/04

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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
Middle name
Last name Tempei Otsubo
Organization Tokyo Women's Medical University Medical Center East
Division name Departement of Psychiatry
Zip code
Address 2-1-10 Nishiogu Arakawa Tokyo Japan
TEL 03-3810-1111
Email otsubo.tempei@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tempei Otsubo
Organization Tokyo Women's Medical University Medical Center East
Division name Department of psychiatry
Zip code
Address 2-1-10 Nishiogu Arakawa Tokyo Japan
TEL 03-3810-1111
Homepage URL
Email otsubo.tempei@twmu.ac.jp

Sponsor
Institute JCHO Tokyo Shinjuku Medical Center
Institute
Department

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
Address
Tel
Email

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
Publication of results Unpublished

Result
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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2017 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033616

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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