UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043421 |
|---|---|
| Receipt number | 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 | 2024/04/13 10:28:17 |
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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
iyom@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Aiko |
| Middle name | |
| Last name | Sato |
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
aikosato@chiba-u.jp
Sponsor or person
Institute
Chiba university hospital
Institute
Department
Personal name
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
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
| 2024 | 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) ,bipolarity
4 State-Trait Anxiety Inventory (STAI)
5 Liebowitz Social Anxiety Scale (LSAS-J)
6 Autism-Spectrum Quotient (AQ)
7 Japanese Adult Reading Test 25(JART25)
8 Event-Related Psychological Distress rating scale 24 (ERPD-24)
9 Impact of Event Scale-Revised (IES-R)
10 about anxious-depressive attack (ADA)
11 Clinical Global Impression of Change (CGI-C)
Management information
Registered date
| 2021 | Year | 02 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049347
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