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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023588
Receipt No. R000027158
Scientific Title Using blood level measurement to gauge the targeting dose of Ketamine infusion in treatment refractory depression.
Date of disclosure of the study information 2016/12/31
Last modified on 2018/03/08

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Basic information
Public title Using blood level measurement to gauge the targeting dose of Ketamine infusion in treatment refractory depression.
Acronym Single Low-Dose Ketamine Injection in
Treating Major Depression
Scientific Title Using blood level measurement to gauge the targeting dose of Ketamine infusion in treatment refractory depression.
Scientific Title:Acronym Single Low-Dose Ketamine Injection in
Treating Major Depression
Region
Asia(except Japan)

Condition
Condition Single Low-Dose Ketamine Injection in
Treating Major Depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The optimal dose of intravenous ketamine for major depression in Chinese population
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The higher dose of intravenous ketamine needed for major depression in Chinese population
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
Other
Interventions/Control_1 Ketamine(0.8mg/kg)
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 1.Diagnosis of major depressive disorder.
2.Voluntary patients with signed informed consent proved by institutional review board (IRB)
3.Age>=20y/o<65 y/o
Key exclusion criteria 1.Major medical conditions (e.g., head injury, epilepsy, severe renal and cancer).
2.Pregnancy
3.Use of CNS intoxicant (eq. cocaine, cannabis, opiates) within the previous 24 hours.
4.Symptoms of substance abuse/dependence(except nicotine dependence) within 6 months
5.Lifetime use of ketamine or phencyclidine (PCP)
6.Diagnosis of psychosis or bipolar disorder
7.current NMDA antagonist medication (eq. Amantadine, Rimantadine, Lamotrigine, Memantine, Dextromethorphan)
8.Actively trying to commit suicide even in a hospital setting
9.Current homicide risk
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mu-Hong Chen
Organization Taipei Veterans General Hospital,Taiwan
Division name Psychiatry Department
Zip code
Address No.201, Sec.2, Shih-Pai Rd, Beitou district, Taipei, Taiwan
TEL +886-2-28757027
Email kremer7119@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Mu-Hong Chen
Organization Taipei Veterans General Hospital,Taiwan
Division name Psychiatry Department
Zip code
Address No.201, Sec.2, Shih-Pai Rd, Beitou district, Taipei, Taiwan
TEL +886-2-28757027
Homepage URL
Email kremer7119@gmail.com

Sponsor
Institute Taipei Veterans General Hospital
Institute
Department

Funding Source
Organization Taipei Veterans General Hospital
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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 31 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
2016 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2016 Year 09 Month 30 Day
Date of closure to data entry
2016 Year 11 Month 01 Day
Date trial data considered complete
2016 Year 11 Month 30 Day
Date analysis concluded
2016 Year 12 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 10 Day
Last modified on
2018 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027158

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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