UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Benzodiazepine Agent Tapering Trial in Japan
Title of the study (Brief title)	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	Keiko Hara
Organization	National Center of Neurology and Psychiatry
Division name	pharmacy
Address	4-1-1 ogawahigashicyo,Kodaira city,Tokyo
TEL	042-341-2711
Email	yakuzai4@ncnp.go.jp

Public contact
Name of contact person	Keiko Hara
Organization	National Center of Neurology and Psychiatry
Division name	Pharmacy
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 03 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000020352