UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031006 |
|---|---|
| Receipt number | R000035400 |
| Scientific Title | Relationship between depression severity and early maladaptive sc hema by questionnaire survey |
| Date of disclosure of the study information | 2018/01/27 |
| Last modified on | 2024/02/01 21:37:28 |
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Basic information
Public title
Relationship between depression
severity and early maladaptive sc
hema by questionnaire survey
Acronym
Relationship between depression
severity and early maladaptive sc
hema
Scientific Title
Relationship between depression
severity and early maladaptive sc
hema by questionnaire survey
Scientific Title:Acronym
Relationship between depression
severity and early maladaptive sc
hema
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploring the relationship between depression severity of patients with depression and early maladaptive schema
Basic objectives2
Others
Basic objectives -Others
Explore characteristics of early maladaptive schema of depressed patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BDI-II:Beck Depression Inventory 2nd edition
YSQ:Young Schema Questionnaire
Key secondary outcomes
SMI:Schema Mode Inventory
ECR-RS:Experience of Close Relationship-Relationship Structure
M.I.N.I:Mini International Neuropsychiatric Interview
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Clinical group
1)Correspond to depression:mental disease simple posture Creator interview The Mini-International Neuropsychiatric Interview:M.I.
N.I.is based.
2)Value of BDI-2 is 14 points or more
3)Depression duration is over 2 years
4)The age at agreement acquisition is less than 60 years old 20 years old or older. The sex does not matter
5)Person who obtains document consent by his / her own free will
6)With or without medication the rapy is not required
2.Non-Cinical group
1)Dose not correspond to depression:mental disease simple posture Creator interview The Mini-International Neuropsychiatric Interview:M.I.N.I.is based. and, Those who have no history of depression
2)The age at agreement acquisition is less than 60 years old 20 years old or older. The sex does not matter)
Key exclusion criteria
1)organic brain disorder
2)active suicidality
3)antisocial personality disorder
4)Mental retardation
5)Person who can not obtain document consent by his / her free will
6)The person who, in addition, judged it though a study person in charge or a study partaker carried out the final examination safely if was inappropriate
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Shimizu |
Organization
Graduate School of Medicine Chiba University
Division name
Department of Cognitive Behavio ral Physiology, Research Center f or Child Mental Development
Zip code
Address
1-8-1 Inohana, Chuou-ku, Chiba, Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomokazu Murata |
Organization
Research Center for Child Mental Development Chiba University
Division name
Department of Cognitive Informa tion Technology
Zip code
Address
1-8-1 Inohana, Chuou-ku, Chiba, Japan
TEL
043-226-2975
Homepage URL
murata@chiba-u.jp
Sponsor or person
Institute
Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Research Center for Child Mental Development, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2018 | Year | 01 | Month | 27 | 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
Main results already published
Date of protocol fixation
| 2017 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 05 | Day |
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 12 | Month | 01 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2018 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035400
