UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intervention trials for prevention of metabolic dysfunction among patients with schizophrenia
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Toshiyuki Someya
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Psychiatry
Address	757 Asahimachidori-ichibancho, Chuo-ku, Niigata
TEL	025-227-2213
Email	psy@med.niigata-u.ac.jp

Public contact
Name of contact person	Mikiko Kitahara
Organization	Japan Psychiatric Hospitals Association
Division name	Secretariat
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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