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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004511
Receipt No. R000005391
Scientific Title The clinical study to correct multiple and large amount of administering to antipsychotic safely and effectively
Date of disclosure of the study information 2010/11/10
Last modified on 2015/03/04

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Basic information
Public title The clinical study to correct multiple and large amount of administering to antipsychotic safely and effectively
Acronym The clinical study to correct multiple and large amount of administering to antipsychotic
Scientific Title The clinical study to correct multiple and large amount of administering to antipsychotic safely and effectively
Scientific Title:Acronym The clinical study to correct multiple and large amount of administering to antipsychotic
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Psychotic symptoms and QOL improve or not, when losing dosage the antipsychotics
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Manchester scale, EuroQOL
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dosage losing of antipsychotics
Interventions/Control_2 control
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 Inpatient/ Outpatient who has schizophrenia.
Taking antipsychotics 2 or more drugs and 500~1500mg/day(chrolpromazine).
Taken informed consent.

Key exclusion criteria Who have severe physical disease.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nakao Iwata
Organization School of medicine, Fujita health university
Division name Dept of psychiatry,
Zip code
Address Kutsukake-cho Toyoake, Aichi
TEL 0562-93-9250
Email nakao@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Yamanouchi
Organization School of medicine, Fujita health university
Division name Dept of psychiatry
Zip code
Address Toyoake, Aichi
TEL 042-341-2711
Homepage URL
Email yamanouchi@ncnp.go.jp

Sponsor
Institute Dept of Psychiatry, School of medicine, Fujita health university
Institute
Department

Funding Source
Organization MHLW
Organization
Division
Category of Funding 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 鳥取医療センター
小嶺江藤病院
医療福祉センター倉吉病院
沼津中央病院
日明病院
一陽病院
東京青梅病院
大分下郡病院
土佐病院
森本病院
虹と海のホスピタル(進藤病院)
西川病院
若草病院
石橋病院
新阿武山病院
武蔵野中央病院
桶狭間病院
修徳会林病院
琉球病院
黒野病院
天久台病院
山容病院
明生病院
太宰府病院
こころの医療センター駒ヶ根
南ヶ丘病院
聖十字病院
共和病院
仁大病院
国立病院機構北陸病院
医療法人社団一秀会 葛飾橋病院
東尾張病院
水明会 佐潟荘
高松病院
布袋病院
八幡厚生病院
日野病院
汐入メンタルクリニック
筑波東病院
朝日病院
平塚病院
河田病院
三枚橋病院
偕成会住吉病院
静岡県立こころの医療センター
泉原病院
さいがた病院
晴和病院
愛宕病院
渡川病院

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncnp.go.jp/nimh/syakai/01_project06.html
Number of participants that the trial has enrolled
Results
Subjects safety and effects did not change by SCAP method.
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
2010 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2013 Year 02 Month 01 Day
Date of closure to data entry
2013 Year 02 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 05 Day
Last modified on
2015 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005391

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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