UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016985 |
|---|---|
| Receipt number | R000019001 |
| Scientific Title | Fast Antidepressant Efficacy and Central Mechanisms of Single Low-Dose Ketamine Injection in Treating Major Depression: a double-blind and randomized-controlled trial and image study |
| Date of disclosure of the study information | 2016/06/30 |
| Last modified on | 2021/11/18 12:14:16 |
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Basic information
Public title
Fast Antidepressant Efficacy and Central Mechanisms of Single Low-Dose Ketamine Injection in
Treating Major Depression: a double-blind and randomized-controlled trial and image study
Acronym
Single Low-Dose Ketamine Injection in
Treating Major Depression
Scientific Title
Fast Antidepressant Efficacy and Central Mechanisms of Single Low-Dose Ketamine Injection in
Treating Major Depression: a double-blind and randomized-controlled trial and image study
Scientific Title:Acronym
Single Low-Dose Ketamine Injection in
Treating Major Depression
Region
| Asia(except Japan) |
Condition
Condition
Treatment-resistant depression, TRD
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the project combined with image studies to
study the specific antidepressant mechanisms of ketamine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PET
MRI
MADRS
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ketamine 0.5mg/kg
Interventions/Control_2
Ketamine 0.2mg/kg
Interventions/Control_3
PBO
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
72
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Cheng-Ta Li |
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
+81-1886228757027
on5083@msn.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Cheng-Ta Li |
Organization
Taipei Veterans General Hospital
Division name
Psychiatry
Zip code
Address
No.201, Sec.2, Shih-Pai Road, Beitou district
TEL
+81-1886228757027
Homepage URL
on5083@msn.com
Sponsor or person
Institute
Ministry of Science and Technology
Institute
Department
Personal name
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
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
Taipei Veterans General Hospital(Taiwan)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | 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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 31 | Day |
Last modified on
| 2021 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019001
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
