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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033916
Receipt No. R000038508
Scientific Title A double-blind, randomized-controlled trial using a low dose of ketamine vs. active placebo in treating severe depression and suicide.
Date of disclosure of the study information 2021/11/30
Last modified on 2021/11/18

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Basic information
Public title A double-blind, randomized-controlled trial using a low dose of ketamine vs. active placebo in treating severe depression and suicide.
Acronym Efficacy of a low dose of ketamine infusion for the rapid anti-depression and anti-suicidal ideations.
Scientific Title A double-blind, randomized-controlled trial using a low dose of ketamine vs. active placebo in treating severe depression and suicide.
Scientific Title:Acronym Efficacy of a low dose of ketamine infusion for the rapid anti-depression and anti-suicidal ideations.
Region
Asia(except Japan)

Condition
Condition Major depression including unipolar and bipolar depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 0.5mg/kg Ketamine vs. active placebo (0.045mg/kg Midazolam)
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 0.5mg/kg Ketamine
Interventions/Control_2 0.045mg/kg Midazolam
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 1)Major depression including unipolar and bipolar depression, according to DSM-IV criteria and MINI (MiniInternational Neuropsychiatric Interview;MINI) diagnostic interview.
2)voluntary patients with signed informed consent proved by institutional review board (IRB)
Key exclusion criteria 1)Major medical conditions (e.g., head injury, epilepsy, severe renal diseases and cancer).
2)Other axis I psychiatric disorders such as schizophrenia, delusional disorder, organic brain syndrome, and dementia.
3)Pregnancy.
4)Substance abuse in previous 6 months.
5)Current use of NMDA receptor antagonist.
6)Attempt suicide in hospital.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name Mu-Hong
Middle name
Last name Chen
Organization Taipei Veterans General Hospital
Division name Department of Psychiatry
Zip code 112
Address No. 201, Shih-Pai Road, Sec. 2, 11217, Taipei, Taiwan.
TEL +886228712121
Email kremer7119@gmail.com

Public contact
Name of contact person
1st name Mu-Hong
Middle name
Last name Chen
Organization Taipei Veterans General Hospital, Taiwan
Division name Department of Psychiatry
Zip code 112
Address No. 201, Shih-Pai Road, Sec. 2, 11217, Taipei, Taiwan.
TEL +886228712121
Homepage URL
Email kremer7119@gmail.com

Sponsor
Institute Ministry of Science and Technology
Institute
Department

Funding Source
Organization Ministry of Science and Technology
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 Institutional Review Board Taipei Veterans General Hospital,Taiwan
Address No. 201, Shih-Pai Road, Sec. 2, 11217, Taipei, Taiwan.
Tel +886228757384
Email irbopinion@vghtpe.gov.tw

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
2021 Year 11 Month 30 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 Open public recruiting
Date of protocol fixation
2018 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 15 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 27 Day
Last modified on
2021 Year 11 Month 18 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038508

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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