UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059848 |
|---|---|
| Receipt number | R000068437 |
| Scientific Title | Maintenance of antidepressant effect by magnetic modulation (rTMS) among patients with treatment-resistant depression who responded to low dose ketamine infusion: a double-blind randomized sham rTMS-controlled study |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/06/01 17:29:37 |
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Basic information
Public title
Maintenance of antidepressant effect by magnetic modulation (rTMS) among patients with treatment-resistant depression who responded to low dose ketamine infusion: a double-blind randomized sham rTMS-controlled study
Acronym
Ketamine+rTMS Study
Scientific Title
Maintenance of antidepressant effect by magnetic modulation (rTMS) among patients with treatment-resistant depression who responded to low dose ketamine infusion: a double-blind randomized sham rTMS-controlled study
Scientific Title:Acronym
ketamine+rTMS study
Region
| Asia(except Japan) |
Condition
Condition
Treatment-resistant depression (TRD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
If the efficacy of ketamine infusion + rTMS is greater than ketamine + srTMS, it will approve prolongation/enhancement of ketamine efficacy by physical electronic stimulation and will provide a novel treatment strategy for patients with TRD in the future.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRI,MADRS,HAMD
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ketamine 0.5mg+rTMS
Interventions/Control_2
Ketamine 0.5mg+sham rTMS
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Major depressive episode including unipolar and bipolar depression, according to
DSM-5 criteria and MINI (Mini International Neuropsychiatric Interview;MINI)
diagnostic interview
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 and Breastfeeding women
4)Substance abuse in previous 6 months such as cocaine, marijuana, opium, ketamine, PCP phencyclidine.
5)Current use of NMDA receptor antagonist Amantadine, Rimantadine, Lamotrigine,Memantine, Dextromethorphan
6)Alcohol abuse and dependence within 6 months.
7)Allergy to Ketamine and Rapamycin.
8)Implanted cardiac pacemaker within 30 cm or metal material like vessel clip in the brain.
9)Those are unable to express willingness to participate.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tung-Ping |
| Middle name | Tom |
| Last name | Su |
Organization
Cheng-Hsin General Hospital
Division name
Department of Psychiatry
Zip code
112
Address
No.45,Cheng Hsin St.,Pai-Tou,Taipei, Taiwan (R.O.C.)
TEL
+886-928593009
tomsu0402@gmail.com
Public contact
Name of contact person
| 1st name | Tung-Ping |
| Middle name | Tom |
| Last name | Su |
Organization
Cheng-Hsin General Hospital
Division name
Department of Psychiatry
Zip code
112
Address
No.45,Cheng Hsin St.,Pai-Tou,Taipei, Taiwan (R.O.C.)
TEL
+886-928593009
Homepage URL
tomsu0402@gmail.com
Sponsor or person
Institute
Su Kunbo Medical Research Foundation
Institute
Department
Personal name
Funding Source
Organization
Su Kunbo Medical Research Foundation
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
Cheng-Hsin General Hospital
Address
No.45,Cheng Hsin St.,Pai-Tou,Taipei, Taiwan (R.O.C.)
Tel
886-2-28264400
irb@chgh.org.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
Cheng-Hsin General Hospital
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 01 | 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
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 21 | Day |
Last modified on
| 2026 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068437
