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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022912
Receipt No. R000026212
Scientific Title Psychological distress symptoms associated with life events in patients with bipolar disorder
Date of disclosure of the study information 2016/06/27
Last modified on 2018/06/28

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

Condition
Condition Bipolar disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the presence of psychological distress symptoms, especially intrusions and avoidance, in patients with BP.
To assess the severity and feature of psychological distress symptoms depend on mood states, mania, euthymia and depression.
Basic objectives2 Others
Basic objectives -Others assessment of psychiatric symptoms
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The prevalence rate of subjects with psychological distress symptoms related to their life events (We investigate the rate of whole subjects and those of each group)
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 1 Patients with current DSM-5 Bipolar Disorder
2 Written informed consent by patients
and more than 19 years old, less than 65 years old
3 Patients who are commuting to or hospitalized in Chiba university hospital, Kisarazu hospital,or Sodegaura satsukidai hospital
Key exclusion criteria 1 Patients with schizophrenia, major depression disorder, comorbid dementia, organic mental disorder, mental retardation
2 significant risk of suicide
3 Patients whom examination doctor judge improper as a trial subject
Target sample size 93

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaomi Iyo
Organization Chiba University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-222-7171(ext5374)
Email iyom@faculty.chiba-u.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 043-222-7171(ext5374)
Homepage URL
Email t.hashimoto1109@gmail.com

Sponsor
Institute Department of Psychiatry,Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kusaka clinic as an endowment
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kisarazu Hospital
Sodegaura Satsukidai Hospital
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 06 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2016 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design:cross-sectional study
Way to recruit:We recruit patients who meet inclusion criteria and who are commuting to or hospitalized in Chiba university hospital, Kisarazu hospital,or Sodegaura satsukidai hospital from June 2016 to May 2017.
Scales:
1 The Mini-International Neuropsychiatric Interview (M.I.N.I.)
2 The Hamilton Depression Ratinng Scale (HDRS)
3 The Young Mania Rating Scale (YMRS)
4 Profile of Mood States (POMS)
5 Impact of Event Scale-Revised (IES-R)
6 Life Change Units Value(LCU)

Management information
Registered date
2016 Year 06 Month 27 Day
Last modified on
2018 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026212

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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