UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033916 |
|---|---|
| Receipt number | 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 | 2023/10/30 15:44:01 |
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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
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
kremer7119@gmail.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
Institutional Review Board Taipei Veterans General Hospital,Taiwan
Address
No. 201, Shih-Pai Road, Sec. 2, 11217, Taipei, Taiwan.
Tel
+886228757384
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
https://wsts.nstc.gov.tw/STSWeb/Award/AwardMultiQuery.aspx?year=107&code=QS01&organ=&name=%e9%99%b3%
Publication of results
Published
Result
URL related to results and publications
https://wsts.nstc.gov.tw/STSWeb/Award/AwardMultiQuery.aspx?year=107&code=QS01&organ=&name=%e9%99%b3%
Number of participants that the trial has enrolled
48
Results
Based on MADRS and HDRS scores, GEE models showed a significant difference in depressive symptoms between ketamine and midazolam groups (p=0.024 by MADRS, p=0.028 by HDRS) in the 2-week follow-up.
Results date posted
| 2023 | Year | 10 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
48 patients with TRD and prominent suicidal ideation were randomly assigned into two treatment groups: 0.5 mg/kg ketamine or midazolam (placebo) infusion.
Participant flow
Between 2018 and 2021, 48 patients with TRD and prominent suicidal ideation were randomly assigned into two treatment groups: 0.5 mg/kg ketamine or midazolam (placebo) infusion. The Montgomery- Asberg Depression Rating Scale (MADRS)and Hamilton Depression Rating Scale (HDRS) were applied prior to initiation of test infusions, at 40, 80 and 240 min postinfusion, and sequentially on Days 2, 3, 5, 7, and 14 after ketamine or placebo infusions. Generalized estimating equations (GEE) were performed to assess the symptom trajectory (MADRS and HDRS between case and control groups. In addition, baseline cognitive functions were also examined and were analyzed for the relationship with treatment efficacy of low-dose ketamine infusion.
Adverse events
Adverse events: No
Outcome measures
A single low-dose ketamine infusion was effective in reducing suicidal ideation among Taiwanese patients with TRD and prominent suicidal ideation. Ketamine-related antidepressant effect persisted for 2 weeks, but related antisuicidal effect only lasted for 5 days. Our clinical outcome may imply that repeated doses of low-dose ketamine infusion may be required for patients with TRD and prominent suicidal ideation. In addition, an inverse relationship between pretreatment working memory function and treatment response to ketamine infusion may confirm that low-dose ketamine infusion is beneficial and should be reserved for patients with TRD.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 30 | Day |
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
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038508
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