UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017765 |
|---|---|
| Receipt number | 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 13:40:37 |
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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
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
yakuzai4@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020352
