UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046150 |
|---|---|
| Receipt number | R000052674 |
| Scientific Title | Modulation of the antidepressant response of ketamine by an immunosuppressant and mTORC1 inhibitor, Rapamycin: a prospective study using randomized, double-blind, placebo controlled clinical trial |
| Date of disclosure of the study information | 2021/11/23 |
| Last modified on | 2025/11/21 17:19:05 |
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Basic information
Public title
Modulation of the antidepressant response of ketamine by an immunosuppressant and mTORC1 inhibitor, Rapamycin: a prospective study using randomized, double-blind, placebo controlled clinical trial
Acronym
Modulation of the antidepressant response of ketamine by an immunosuppressant and mTORC1 inhibitor, Rapamycin
Scientific Title
Modulation of the antidepressant response of ketamine by an immunosuppressant and mTORC1 inhibitor, Rapamycin: a prospective study using randomized, double-blind, placebo controlled clinical trial
Scientific Title:Acronym
Modulation of the antidepressant response of ketamine by an immunosuppressant and mTORC1 inhibitor, Rapamycin: a prospective study using randomized, double-blind, placebo controlled clinical trial
Region
| Asia(except Japan) |
Condition
Condition
Treatment Resistance Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The results will provide the evidence of using immunosuppressant Rapamycin would prolong and enhance the therapeutic effect of ketamine in the treatment of TRD patients with suicide ideation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Our aims are to assess the role of rapamycin in ketamine treatment of TRD patients and to test if rapamycin might enhance and prolong the antidepressant effect of ketamine. For that, we will conduct a parallel, randomized, double blind and placebo controlled study.
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
oral rapamycin 6 mg + ketamine (0.5mg/kg) infusion
Interventions/Control_2
oral placebo + ketamine (0.5mg/kg) infusion
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Major depressive episode including unipolar and bipolar depression, according to
DSM-5
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 / dependence within 6 months.
7) Allergy to Ketamine and Rapamycin
8)Those unable to express willingness to participate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Su |
| Middle name | Tung-Ping |
| Last name | Su Tung-Ping |
Organization
CHENG HSIN GENERAL HOSPITAL
Division name
Department of Psychiatry
Zip code
112
Address
No.45,Cheng Hsin St.,Pai-Tou,Taipei
TEL
02-28264400
tomsu0402@gmail.com
Public contact
Name of contact person
| 1st name | Su |
| Middle name | Tung-Ping |
| Last name | Su Tung-Ping |
Organization
CHENG HSIN GENERAL HOSPITAL
Division name
Department of Psychiatry
Zip code
112
Address
No.45,Cheng Hsin St.,Pai-Tou,Taipei
TEL
02-28264400
Homepage URL
tomsu0402@gmail.com
Sponsor or person
Institute
CHENG HSIN GENERAL HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
CHENG HSIN 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
CHENG HSIN GENERAL HOSPITAL
Address
No.45,Cheng Hsin St.,Pai-Tou,Taipei
Tel
02-28264400
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
| 2021 | Year | 11 | Month | 23 | Day |
Related information
URL releasing protocol
NO
Publication of results
Unpublished
Result
URL related to results and publications
No
Number of participants that the trial has enrolled
50
Results
Results:
A total of 50 participants were randomized (rapamycin n=23, placebo n=27). Two participants withdrew; 48 completed the trial. The response rate at Week 2 was 41% in the rapamycin group vs 13% in placebo (p=0.04, effect size 1.0). Rapamycin did not alter the acute antidepressant effect of ketamine but appeared to prolong its therapeutic duration.
Results date posted
| 2025 | Year | 11 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Total enrolled: 50
Study arms: 2 (Rapamycin + Ketamine; Placebo + Ketamine)
Completed: 48
Gender (M/F): 14 / 36
Mean age: 38 years
Primary diagnosis: Treatment-resistant major depressive disorder
Participant flow
Total enrolled: 50
Study arms: 2 (Rapamycin + Ketamine; Placebo + Ketamine)
Completed: 48
Gender (M/F): 14 / 36
Mean age: 38 years
Adverse events
N/A
Outcome measures
MADRS score change after ketamine infusion
Time frame: 24 hours after ketamine administration
Description: Change in Montgomery Asberg Depression Rating Scale (MADRS) score from baseline to 24 hours post infusion.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 23 | Day |
Last modified on
| 2025 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052674
