UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Psychological distress symptoms associated with life events in patients with bipolar disorder
Title of the study (Brief title)	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	Masaomi Iyo
Organization	Chiba University Graduate School of Medicine
Division name	Department of Psychiatry
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	Tasuku Hashimoto
Organization	Chiba University Graduate School of Medicine
Division name	Department of Psychiatry
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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