UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022912 |
|---|---|
| Receipt number | 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 18:12:44 |
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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)
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
t.hashimoto1109@gmail.com
Sponsor or person
Institute
Department of Psychiatry,Chiba University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026212
