UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The observational study to examine factors which improve the subjective anxiety beyond the clinician's prediction in psychiatric patients
Title of the study (Brief title)	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	Masaru Mimura
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-5363-3971
Email	hiroyuki.uchida.hu@gmail.com

Public contact
Name of contact person	Hitoshi Sakurai
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027400