UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026499 |
|---|---|
| Receipt number | R000030432 |
| Scientific Title | Tapering Multiple Benzodiazepine Drugs study through investigating Cognition and Risk of Side Effects for Depression |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2019/03/14 11:21:53 |
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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
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
koshikay@takii.kmu.ac.jp
Public contact
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
koshikay@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai medical university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030432
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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