UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035197 |
|---|---|
| Receipt number | R000039838 |
| Scientific Title | Investigation of comorbidity, treatment resistance, severity, functional disability, QOL for psychiatric disorders. |
| Date of disclosure of the study information | 2018/12/11 |
| Last modified on | 2021/12/11 10:10:06 |
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Basic information
Public title
Investigation of comorbidity, treatment resistance, severity, functional disability, QOL for psychiatric disorders.
Acronym
Investigation of comorbidity, treatment resistance, severity, functional disability, QOL for psychiatric disorders.
Scientific Title
Investigation of comorbidity, treatment resistance, severity, functional disability, QOL for psychiatric disorders.
Scientific Title:Acronym
Investigation of comorbidity, treatment resistance, severity, functional disability, QOL for psychiatric disorders.
Region
| Japan |
Condition
Condition
Depressive disorder, Persistent Depressive Disorder, Bipolar 1 disorder, Bipolar 2 Disorder, Panic Disorder, Agoraphobia, Social anxiety Disorder, Obsessive-Compulsive disorder, PTSD, Substance related disorder, Anorexia nervosa, Bulimia Nervosa, General anxiety disorder (DSM-5)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate factors of vulnerability, treatment resistant, or functional disablity.
Basic objectives2
Others
Basic objectives -Others
Cohort Study, Cross-sectional Study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
On admission
Interpersonal sensitivity measure: IPSM
Ten Item Personality Inventory: TIPI
Confidant
Parental Bonding Instrument: PBI
BDI-2
EQ5D
Sheehan Disability Scale; SDS
After 28day-42day at admission
BDI-2
EQ5D
Sheehan Disability Scale: SDS
Interpersonal Sensitivity Measure; IPSM
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
| 16 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who started to be admitted to Nagoya City University Hospital (psychiatry, psychosomatic medicine).
2) Patients who were diagnosed Depressive disorder, Persistent Depressive Disorder, Bipolar 1 disorder, Bipolar 2 Disorder, Panic Disorder, Agoraphobia, Social anxiety Disorder, Obsessive-Compulsive disorder, PTSD, Substance related disorder, Anorexia nervosa, Bulimia Nervosa or General anxiety disorder by DSM-5.
Key exclusion criteria
1) Patients who were diagnosed/ strongly suspected neurodevelopment disorders, schizophrenia spectrum and other psychotic disorders, neurocognitive disorders, manic episode, hypomanic episode, epilepsy or mental disorder due to medical condition by DSM-5
2) Patients who can't understand Japanese well.
3) Patients who had participated in this study.
4) Patients who were supposed to be hospitalized in 7 days.
5) Patients who their research doctor consider not suited.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Risa |
| Middle name | |
| Last name | Risa Imai |
Organization
Nagoya City University
Division name
Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
4670001
Address
Kawasumi1 Mizuho-cho Mizuho-ku Nagoya
TEL
052-851-5511
imai.r.nagoya@gmail.com
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Imai |
Organization
Nagoya City University
Division name
Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
4670001
Address
Kawasumi1 Mizuho-cho Mizuho-ku Nagoya
TEL
052-851-5511
Homepage URL
imai.r.nagoya@gmail.com
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University
Address
Mizuho-ku Mizuho-cho Kawasumi1
Tel
052-851-5511
miffy_710vvv@yahoo.co.jp
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 | 12 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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 | 10 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
On admission
Interpersonal sensitivity measure: IPSM
Ten Item Personality Inventory: TIPI
Confidant
Parental Bonding Instrument: PBI
BDI-2
EQ5D
Sheehan Disability Scale; SDS
After 28day-42day at admission
BDI-2
EQ5D
Sheehan Disability Scale: SDS
Interpersonal Sensitivity Measure; IPSM
Management information
Registered date
| 2018 | Year | 12 | Month | 10 | Day |
Last modified on
| 2021 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039838
