UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023898 |
|---|---|
| Receipt number | R000027400 |
| Scientific Title | The observational study to examine factors which improve the subjective anxiety beyond the clinician's prediction in psychiatric patients |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2017/03/03 09:27:33 |
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Basic information
Public title
The observational study to examine factors which improve the subjective anxiety beyond the clinician's prediction in psychiatric patients
Acronym
Examination of factors which improve the subjective anxiety beyond the clinician's prediction
Scientific Title
The observational study to examine factors which improve the subjective anxiety beyond the clinician's prediction in psychiatric patients
Scientific Title:Acronym
Examination of factors which improve the subjective anxiety beyond the clinician's prediction
Region
| Japan |
Condition
Condition
psychiatric inpatients
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine factors which improve the subjective anxiety beyond the clinician's prediction in psychiatric patients.
Basic objectives2
Others
Basic objectives -Others
To predict treatment responses of anxiety symptoms in psychiatric patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences of baseline characteristics between the patients whose subjective anxiety improves from admission to discharge beyond the clinician's prediction and whose one dose not.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
psychiatric inpatients at Keio University hospital
Key exclusion criteria
severe suicidal ideation
severe physical illness
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Mimura |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-5363-3971
hiroyuki.uchida.hu@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Sakurai |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-5363-3971
Homepage URL
jun49_86@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neuropsychiatry, Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 09 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Attending doctors predict the State-Trait Anxiety Inventory(STAI) score at discharge based on the score at admission in psychiatric inpatients. We examine the baseline characteristics in patients whose subjective anxiety improves beyond the objective expectation.
Management information
Registered date
| 2016 | Year | 09 | Month | 01 | Day |
Last modified on
| 2017 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027400
