UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035197
Receipt No. 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 2018/12/10

* 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 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
Middle name
Last name Risa Imai
Organization Nagoya City University
Division name Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
Address Kawasumi1 Mizuho-cho Mizuho-ku Nagoya
TEL 052-851-5511
Email imai.r.nagoya@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Risa Imai
Organization Nagoya City University
Division name Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
Address Kawasumi1 Mizuho-cho Mizuho-ku Nagoya
TEL 052-851-5511
Homepage URL
Email imai.r.nagoya@gmail.com

Sponsor
Institute Nagoya City University
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 14 Day
Last follow-up date
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
2018 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039838

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.