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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014016
Receipt No. R000016235
Scientific Title Intervention trials for prevention of metabolic dysfunction among patients with schizophrenia
Date of disclosure of the study information 2014/06/01
Last modified on 2016/05/31

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Basic information
Public title Intervention trials for prevention of metabolic dysfunction among patients with schizophrenia
Acronym Intervention trials for prevention of metabolic dysfunction among patients with schizophrenia
Scientific Title Intervention trials for prevention of metabolic dysfunction among patients with schizophrenia
Scientific Title:Acronym Intervention trials for prevention of metabolic dysfunction among patients with schizophrenia
Region
Japan

Condition
Condition Metabolic syndrome among patints with schizophrenia
Classification by specialty
Endocrinology and Metabolism Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the preventive effect of non-pharmacological interventions for metabolic dysfunction in patients with schizophrenia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of metabolic syndrome during 1 year
Key secondary outcomes Weight change during 1 year

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 No intervention
Interventions/Control_2 Weigt check at every visit
Interventions/Control_3 Weigt check at every visit, and nutrition education
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
65 years-old >=
Gender Male and Female
Key inclusion criteria (1) Subjects are required to be stabilised and treated with an antipsychotic drug for at least three months.

(2) Subjects have BMI greater than or equal to 25. Or subjects have waist circumference greater than or equal to 90cm in males and 80cm in females.
Key exclusion criteria (1) Subjects have eating disorder, mental retardation and alcohol or substance dependence syndrome.

(2) Subjects under treatment or nutrition education for diabetes.

(3) Subjects were provided nutrition education during past 1 year
Target sample size 540

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Someya
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Psychiatry
Zip code
Address 757 Asahimachidori-ichibancho, Chuo-ku, Niigata
TEL 025-227-2213
Email psy@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mikiko Kitahara
Organization Japan Psychiatric Hospitals Association
Division name Secretariat
Zip code
Address 3-15-14 Shibaura Minato Tokyo
TEL 03-5232-3311
Homepage URL
Email m-kitahara@nisseikyo.or.jp

Sponsor
Institute Joint committee for antipsychotics treatment and physical risk
Institute
Department

Funding Source
Organization Eisai, Yoshitomi, Dainippon Sumitomo,Astellas, Meiji Seika, Eli Lilly, Otsuka, GlaxoSmithKelin, Janssen, MSD,Shionogi, Asahi Kasei, Novartis, Takeda, and Tsumura
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
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
2014 Year 06 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 Completed
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 25 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 21 Day
Last modified on
2016 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016235

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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