UMIN-CTR Clinical Trial

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
Email	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
Email	t.hashimoto1109@gmail.com

Sponsor
Institute	Sodegaura Satsukidai Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028977