UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014016 |
|---|---|
| Receipt number | 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 10:17:05 |
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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
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
m-kitahara@nisseikyo.or.jp
Sponsor or person
Institute
Joint committee for antipsychotics treatment and physical risk
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016235
