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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025206
Receipt No. R000028977
Scientific Title Psychological distress symptoms associated with life events in patients with major depressive disorder
Date of disclosure of the study information 2016/12/09
Last modified on 2017/06/10

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Basic information
Public title Psychological distress symptoms associated with life events in patients with major depressive disorder
Acronym Psychological distress symptoms associated with life events in patients with major depressive disorder
Scientific Title Psychological distress symptoms associated with life events in patients with major depressive disorder
Scientific Title:Acronym Psychological distress symptoms associated with life events in patients with major depressive disorder
Region
Japan

Condition
Condition Majar depressive disordar
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 we chronologically compared with the severity of Life-event-related psychological distress symptoms and of depression,and examin whether there are the relation.

Basic objectives2 Others
Basic objectives -Others we chronologically compared with the severity of Life-event-related psychological distress symptoms and of depression,and examin whether there are the relation.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We assess the severity of PDS and depression with HAM-D and IES-R.
Key secondary outcomes

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
65 years-old >
Gender Male and Female
Key inclusion criteria major depression with first or reccurent depressive episode diagnosed according to DSM-5.
Key exclusion criteria 1. patients with schizophrenia or psychotic disorders, bipolar disorders, comorbid dementia, organic mental disorders, mental retardation
2. significant risk of suicide
3. Patient whom examination doctor judge improper as a trial subject
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Ishige
Organization Sodegaura Satsukidai Hospital
Division name Department of Psychiatry
Zip code
Address 5-21,Nagauraekimae Sodegaura City, Chiba, Japan
TEL +81-438-62-1113
Email ishige@mail.satsuki-kai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tasuku Hashimoto
Organization Chiba University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL +81-43-226-2148
Homepage URL
Email t.hashimoto1109@gmail.com

Sponsor
Institute Sodegaura Satsukidai Hospital
Institute
Department

Funding Source
Organization Sodegaura Satsukidai Hospital
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
2016 Year 12 Month 09 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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 12 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 This is a observation study of depressed outpatients

Management information
Registered date
2016 Year 12 Month 09 Day
Last modified on
2017 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028977

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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