UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of psychiatry consultation patients for whom enteral formulas were prescribed, and exploration of factors affecting persistence of the prescription
Acronym	Investigation of psychiatry consultation patients for whom enteral formulas were prescribed
Scientific Title	Retrospective Cohort Study to investigate psychiatry consultation patients for whom enteral formulas were prescribed and to explore factors affecting persistence of nutritional treatment
Scientific Title:Acronym	Investigation of psychiatry consultation patients for whom enteral formulas were prescribed and exploration of the risk factors
Region	Japan

Condition
Condition	psychiatric disease
Classification by specialty	Medicine in general Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To survey the prescription status (continuation, discontinuation, completion) of enteral formulas for patients in Mental Clinic Minami.
Basic objectives2	Others
Basic objectives -Others	(1)Patient characteristics/ profile (2)Continuation of prescribed enteral formulas
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Rate of discontinuation of enteral formulas
Key secondary outcomes	Adverse events related to enteral formulas

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have attended the clinic from January 1 to December 31, 2020 (both dates inclusive)
Key exclusion criteria	(1)Patients for whom the specified enteral formulas have NOT been prescribed (2)Patients who have been judged as inadequate to entry in this study
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kouichi Middle name Last name Banno
Organization	Mental Clinic Minami
Division name	Psychiatry
Zip code	459-8016
Address	Minami-seikyo yottette-yokochou 2F, 2-701, Minami-Odaka, Midori-ku, Nagoya City, Aichi Prefecture
TEL	062-625-1026
Email	kb19790723@yahoo.co.jp

Public contact
Name of contact person	1st name Yoshihito Middle name Last name Iwanami
Organization	EN Otsuka Pharmaceutical, Co., Ltd.
Division name	R&D Application Office Research & Development Division
Zip code	025-0312
Address	4-3-5, Nimaibashi, Hanamaki City, Iwate Prefecture
TEL	0198-26-5261
Homepage URL
Email	iwanami@enotsuka.co.jp

Sponsor
Institute	Mental Clinic Minami
Institute
Department

Funding Source
Organization	EN Otsuka Pharmaceutical, Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Minami Medical Health Cooperative General Hospital Minami-Seikyo Hospital ethics committee
Address	2-204, Minami-Odaka, Midori-ku, Nagoya City, Aichi Prefecture
Tel	052-625-0373
Email	n-hara@minami.or.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	2021 Year 02 Month 15 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	Open public recruiting
Date of protocol fixation	2020 Year 12 Month 16 Day
Date of IRB	2020 Year 12 Month 17 Day
Anticipated trial start date	2021 Year 01 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	in practice

Management information
Registered date	2021 Year 02 Month 12 Day
Last modified on	2021 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049452

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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