UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025206 |
|---|---|
| Receipt number | 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 | 2019/12/12 09:13:55 |
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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 | Minoru |
| Middle name | |
| Last name | Ishige |
Organization
Sodegaura Satsukidai Hospital
Division name
Department of Psychiatry
Zip code
299-0246
Address
5-21,Nagauraekimae Sodegaura City, Chiba, Japan
TEL
+81-438-62-1113
ishige@mail.satsuki-kai.or.jp
Public contact
Name of contact person
| 1st name | Tasuku |
| Middle name | |
| Last name | Hashimoto |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
+81-43-226-2148
Homepage URL
t.hashimoto1109@gmail.com
Sponsor or person
Institute
Sodegaura Satsukidai Hospital
Institute
Department
Personal name
Funding Source
Organization
Sodegaura Satsukidai Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the IRB committee in Sodegaura Satsukidai Hospital
Address
5-21,Nagauraekimae Sodegaura City, Chiba, Japan
Tel
0438-62-1113
t-hashimoto@faculty.chiba-u.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
| 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
Terminated
Date of protocol fixation
| 2016 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
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
| 2019 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028977
