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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034922
Receipt No. R000039687
Scientific Title Approach to elucidate effect of ketamine on treatment resistant depression
Date of disclosure of the study information 2019/01/01
Last modified on 2019/08/02

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Basic information
Public title Approach to elucidate effect of ketamine on treatment resistant depression
Acronym ketamine and depression
Scientific Title Approach to elucidate effect of ketamine on treatment resistant depression
Scientific Title:Acronym ketamine and depression
Region
Japan

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

Objectives
Narrative objectives1 to elucidate mechanism of antidepressant effect of ketamine
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes antidepressant effect measurement of ketamine
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 Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of ketamine ( 0.5mg/kg ) for 40 min every 7 days for 2 week
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
65 years-old >=
Gender Male and Female
Key inclusion criteria treatment resistant depression
Key exclusion criteria patients whom the psychiatrist diagnose inappropriate
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kudo
Middle name
Last name Takashi
Organization Hirosaki University Hospital
Division name department of anesthesiology
Zip code 0368563
Address 53 Honcho, Hirosaki city, Aomori, Japan
TEL +81172335111
Email takf5@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name Takash
Middle name
Last name Kudo
Organization Hirosaki University Hospital
Division name department of anesthesiology
Zip code 0368563
Address 53 Honcho, Hirosaki city, Aomori, Japan
TEL +81172335111
Homepage URL
Email takf5@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University Hospital
Institute
Department

Funding Source
Organization Hirosaki University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hirosaki University Graduate School of Medicine Institutional Review Board
Address 5, Zaifucho, Hirosaki, Aomori
Tel 0172395203
Email rinri@hirosaki-u.ac.jp

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
2019 Year 01 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 31 Day
Date of IRB
2019 Year 07 Month 01 Day
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 18 Day
Last modified on
2019 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039687

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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