UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049877 |
|---|---|
| Receipt number | R000056659 |
| Scientific Title | Modulation of the antidepressant and antisuicidal efficacy of low-dose ketamine infusion via the mTORC1 modulator, Rapamycin: A double-blind, randomized, placebo controlled trial combined with the neuropsychological and functional connectivity MRI study. |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2023/03/01 16:03:14 |
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Basic information
Public title
Modulation of the antidepressant and antisuicidal efficacy of low-dose ketamine infusion via the mTORC1 modulator, Rapamycin: A double-blind, randomized, placebo controlled trial combined with the neuropsychological and functional connectivity MRI study.
Acronym
Modulation of the antidepressant and antisuicidal efficacy of low-dose ketamine infusion via the mTORC1 modulator, Rapamycin
Scientific Title
Modulation of the antidepressant and antisuicidal efficacy of low-dose ketamine infusion via the mTORC1 modulator, Rapamycin: A double-blind, randomized, placebo controlled trial combined with the neuropsychological and functional connectivity MRI study.
Scientific Title:Acronym
Modulation of the antidepressant and antisuicidal efficacy of low-dose ketamine infusion via the mTORC1 modulator, Rapamycin
Region
| Asia(except Japan) |
Condition
Condition
treatment-resistant depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess the role of rapamycin in ketamine treatment of TRD patients and to test if rapamycin may enhance and prolong the antidepressant and antisuicidal effect of low-dose ketamine infusion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Changes in depressive symptoms measured by Montgomery-Asberg Depression Rating Scale (MADRS) in adults with treatment-resistant depression.
2. Changes in depressive symptoms measured by Hamilton Rating Scale for Depression (HAMD) in adults with treatment-resistant depression.
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
Arm1: Ketamine (0.5mg/kg) infusion and oral rapamycin (6mg) at three time points
Interventions/Control_2
Arm2: Ketamine (0.5mg/kg) infusion and oral placebo at three time points
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
(1) Major depressive episode including unipolar and bipolar depression, according to DSM-5 criteria and MINI-adolescent version (Mini-International Neuropsychiatric Interview; MINI) diagnostic interview.
(2) Age >= 20y/o < 70 y/o
(3) Voluntary patients and their parents or guardians 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 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) Attempt suicide in hospital.
(8) Allergy to ketamine or rapamycin.
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, Taiwan
Division name
Department of Psychiatry
Zip code
112
Address
No. 201, Shih-Pai Road, Sec. 2, 11217, Taipei, Taiwan.
TEL
+886228757027
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
+886228757027
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
| 2023 | Year | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 23 | Day |
Last modified on
| 2023 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056659
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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