UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043421
Receipt No. R000049347
Scientific Title Evaluation of the Event-Related Psychological Distress Rating Scale (ERPD-24) in patients with mood disorders
Date of disclosure of the study information 2021/02/23
Last modified on 2021/02/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of the Event-Related Psychological Distress Rating Scale (ERPD-24) in patients with mood disorders
Acronym Evaluation of the Event-Related Psychological Distress Rating Scale (ERPD-24) in patients with mood disorders
Scientific Title Evaluation of the Event-Related Psychological Distress Rating Scale (ERPD-24) in patients with mood disorders
Scientific Title:Acronym Evaluation of the Event-Related Psychological Distress Rating Scale (ERPD-24) in patients with mood disorders
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the severity of ERPD by using the ERPD-24 in patients with major depression and bipolar disorder comparing to healthy people.
Basic objectives2 Others
Basic objectives -Others To explore the relationships between ERPD and other clinical features assessed in this study to clarify the pathophysiology of ERPD in those.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Examination of the score and content of a new rating scale (ERPD-24) for bipolar disorder, depression, normal subjects, and different mood states
Key secondary outcomes Relationship between scores on the new rating scale (ERPD-24) and the Quick Inventory of Depressive Symptomatology, the Young Mania Rating Scale, the State-Trait Anxiety Inventory, the Liebowitz Social Anxiety Scale, the Autism-Spectrum Quotient, the ADA(anxious-depressive attack), and the Impact of Event Scale-Revised

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
70 years-old >
Gender Male and Female
Key inclusion criteria 1 Patients who are diagnosed with depression and bipolar disorder according to DSM-5 criteria and healthy people
2 Patients who have ERPD
3 Patients who are commuting to or hospitalized in Chiba university hospital or cooperating medical institutions
Key exclusion criteria 1 Patients with schizophrenia, major depression disorder, comorbid dementia, organic mental disorder, mental retardation
2 Patients who have trauma
3 significant risk of suicide
4 Patients whom examination doctor judge improper as a trial subject
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Masaomi
Middle name
Last name Iyo
Organization Graduate school of medicine and school of medicine, Chiba university
Division name Department of psychiatry
Zip code 260-8677
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
TEL 043-222-7171
Email iyom@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Hiroki
Middle name
Last name Ishii
Organization Graduate school of medicine and school of medicine, Chiba university
Division name Department of psychiatry
Zip code 260-8677
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
TEL 043-222-7171
Homepage URL
Email hirokiemma@chiba-u.jp

Sponsor
Institute Chiba university hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Kokoronokaze Clinic Funabashi
Chiba Prefecture Psychiatric Medical Center
Sodegaura Satsukidai Hospital
Douwakai Chiba Hospital
Fujita Hospital
International University of Health and Welfare Narita Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Graduate school of medicine and school of medicine, Chiba university
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
Tel 043-222-7171
Email None

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
2021 Year 02 Month 23 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 Open public recruiting
Date of protocol fixation
2021 Year 01 Month 09 Day
Date of IRB
2021 Year 02 Month 22 Day
Anticipated trial start date
2021 Year 02 Month 23 Day
Last follow-up date
2023 Year 03 Month 31 Day
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 or cooperating medical institutions from February 2021 to September 2023.
Scales:
1 The Mini-International Neuropsychiatric Interview (M.I.N.I.)
2 Quick Inventory of Depressive Symptomatology (QIDS-J)
3 The Young Mania Rating Scale (YMRS)
4 State-Trait Anxiety Inventory (STAI)
5 Liebowitz Social Anxiety Scale (LSAS-J)
6 Autism-Spectrum Quotient (AQ)
7 Event-Related Psychological Distress rating scale 24 (ERPD-24)
8 Impact of Event Scale-Revised (IES-R)
9 about anxious-depressive attack (ADA)
10 Clinical Global Impression of Change (CGI-C)

Management information
Registered date
2021 Year 02 Month 23 Day
Last modified on
2021 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049347

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.