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 2021/11/23 16:59:03

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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 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

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

Value
https://center6.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