UMIN-CTR Clinical Trial

Basic information
Public title	Tapering Multiple Benzodiazepine Drugs study through investigating Cognition and Risk of Side Effects for Depression
Acronym	Tapering Multiple Benzodiazepine Drugs study through investigating Cognition and Risk of Side Effects for Depression
Scientific Title	Tapering Multiple Benzodiazepine Drugs study through investigating Cognition and Risk of Side Effects for Depression
Scientific Title:Acronym	Tapering Multiple Benzodiazepine Drugs study through investigating Cognition and Risk of Side Effects for Depression
Region	Japan

Condition
Condition	depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is investigating of the benefit and risk to taper benzodiazepine, especially neurocognition.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	.Nerurocognitive battery
Key secondary outcomes	.Cognitive Failures Questionnaire .Hamilton depression scale .Athens insomnia scale .State-Trait Anxiety Inventory .Social Adaptation Self-evaluation Scale .the clinical withdrawal assessment scale for benzodiazepines

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tapering of anti-anxiety Agents or hypnotics benzodiazepines. If the patient take anti-anxiety agents or hypnotics of benzodiazepine convert diazepam 15mg and above or two kinds, the subject is study 1 group. If the patient take anti-anxiety agents or hypnotics of benzodiazepine convert diazepam under 15mg or one kind, the subjects is study 2 group. Treatment duration is 16 weeks. In taper group, drugs are taper half per one month firstly and maintain the quantity of drug(s).
Interventions/Control_2	the control group is maintain the quantity of anti-anxiety agents or hypnotics of benzodiazepine until the end of this study.
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	Patients with major depression who diagnosed by DSM-5 and take anti-anxiety agents or hypnotics of benzodiazepine.
Key exclusion criteria	Patients who contract disease affecting cognitive disfunction, for example epilepsy, alcohol dependence syndrome and so on. Pregnant patients.
Target sample size	80

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yosuke Koshikawa
Organization	Kansai medical university
Division name	The department of neuropsychiatry
Zip code
Address	10-15 fumizono-cho, Moriguchi, Osaka, Japan
TEL	06-6992-1001
Email	koshikay@takii.kmu.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Yosuke Koshikawa
Organization	Kansai medical university
Division name	The department of neuropsychiatry
Zip code
Address	10-15 fumizono-cho, Moriguchi, Osaka, Japan
TEL	06-6992-1001
Homepage URL
Email	koshikay@takii.kmu.ac.jp

Sponsor
Institute	Kansai medical university
Institute
Department

Funding Source
Organization	Kansai medical university
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

Other administrative information
Date of disclosure of the study information	2017 Year 04 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	Terminated
Date of protocol fixation	2014 Year 12 Month 16 Day
Date of IRB	2015 Year 02 Month 05 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2017 Year 12 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 03 Month 10 Day
Last modified on	2019 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030432