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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033760
Receipt No. R000038444
Scientific Title A low dose of ketamine infusion for acute and maintenance treatment for severe depression and suicide: a double-blind, randomized-controlled study.
Date of disclosure of the study information 2018/08/15
Last modified on 2019/07/09

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Basic information
Public title A low dose of ketamine infusion for acute and maintenance treatment for severe depression and suicide: a double-blind, randomized-controlled study.
Acronym A low dose of ketamine infusion for acute and maintenance treatment for severe depression and suicide.
Scientific Title A low dose of ketamine infusion for acute and maintenance treatment for severe depression and suicide: a double-blind, randomized-controlled study.
Scientific Title:Acronym A low dose of ketamine infusion for acute and maintenance treatment for severe depression and suicide.
Region
Asia(except Japan)

Condition
Condition Treatment-resistant depression, TRD
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Treating Severe Depression and Suicide
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Decreasing rate of suicide symptom postinfusion of ketamine
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ketamine 0.5mg/kg
Interventions/Control_2 Midazolam 0.045mg/kg
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 diagnosis of major depressive disorder according to
Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision
(DSM-IV-TR)
Key exclusion criteria 1) Use of CNS intoxicant within the previous 24 hours or urine toxicology screen positive for drugs of abuse
2) Overdose, within previous 24 hours, of any agent which would compromise
ketamine metabolism
3) Symptoms of substance abuse/dependence(except nicotine dependence) within 6
months
4) Lifetime use of ketamine or phencyclidine(PCP)
5) Diagnosis of psychosis or bipolar disorder
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tung-Ping Su
Organization CHENG HSIN GENERAL HOSPITAL
Division name Department of Psychiatry
Zip code
Address No.45,Cheng Hsin St.,Pai-Tou,Taipei
TEL 02-28264400
Email tomsu0402@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tung-Ping Su
Organization CHENG HSIN GENERAL HOSPITAL
Division name Department of Psychiatry
Zip code
Address No.45,Cheng Hsin St.,Pai-Tou,Taipei
TEL 02-28264400
Homepage URL
Email tomsu0402@gmail.com

Sponsor
Institute CHENG HSIN GENERAL HOSPITAL
Institute
Department

Funding Source
Organization CHENG HSIN GENERAL HOSPITAL,TAIWAN
Organization
Division
Category of Funding Organization Outside Japan
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 CHENG HSIN GENERAL HOSPITAL

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 15 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 Enrolling by invitation
Date of protocol fixation
2018 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 15 Day
Last modified on
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038444

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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