UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017765
Receipt No. R000020352
Scientific Title The Benzodiazepine Agent Tapering Trial in Japan
Date of disclosure of the study information 2015/06/08
Last modified on 2016/12/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The Benzodiazepine Agent Tapering Trial in Japan
Acronym BAT trial
Scientific Title The Benzodiazepine Agent Tapering Trial in Japan
Scientific Title:Acronym BAT trial
Region
Japan

Condition
Condition mental disease
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the objective of the trial is to investigate the effectiveness of direct patient education about benzodiazepine therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes benzodiazepine dose per day
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Educational intervention about benzodiazepine by using a text
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Outpatient who are commuting to daycare
Agreement of patients
Outpatient taking two or more medications benzodiazepine receptor agonist during more than three months
Key exclusion criteria A diagnosis of epilepsy, substance use disorder,Intellectual disability, personality disorder,recognition dysfunction
Inappropriate patients judged by doctor
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiko Hara
Organization National Center of Neurology and Psychiatry
Division name pharmacy
Zip code
Address 4-1-1 ogawahigashicyo,Kodaira city,Tokyo
TEL 042-341-2711
Email yakuzai4@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Hara
Organization National Center of Neurology and Psychiatry
Division name Pharmacy
Zip code
Address 4-1-1 ogawahigashicyo,Kodaira city,Tokyo
TEL 042-341-2711
Homepage URL
Email yakuzai4@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Intramural Research Grant(25-Y3) for Neurological and Psychiatric Disorders of NCNP
Organization
Division
Category of Funding Organization Other
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 国立精神神経医療研究センター 精神科デイケア

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Preinitiation
Date of protocol fixation
2015 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 15 Day
Last follow-up date
2016 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 01 Day
Last modified on
2016 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020352

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.