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Recruitment status Terminated
Unique ID issued by UMIN UMIN000023898
Receipt No. 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

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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
Last 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
Email hiroyuki.uchida.hu@gmail.com

Public contact
1st 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
Email jun49_86@yahoo.co.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027400

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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