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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046150
Receipt No. 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 2021/11/23

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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
Email 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
Email tomsu0402@gmail.com

Sponsor
Institute CHENG HSIN GENERAL HOSPITAL
Institute
Department

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
Email 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
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
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
2021 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052674

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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