UMIN-CTR Clinical Trial

Basic information
Public title	A low dose of ketamine infusion for acute and maintenance treatment for severe depression and suicide: a double-blind, randomized-controlled study.
Acronym	A low dose of ketamine infusion for acute and maintenance treatment for severe depression and suicide.
Scientific Title	A low dose of ketamine infusion for acute and maintenance treatment for severe depression and suicide: a double-blind, randomized-controlled study.
Scientific Title:Acronym	A low dose of ketamine infusion for acute and maintenance treatment for severe depression and suicide.
Region	Asia(except Japan)

Condition
Condition	Treatment-resistant depression, TRD
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Treating Severe Depression and Suicide
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Decreasing rate of suicide symptom postinfusion of ketamine
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	Ketamine 0.5mg/kg
Interventions/Control_2	Midazolam 0.045mg/kg
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	diagnosis of major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR)
Key exclusion criteria	1) Use of CNS intoxicant within the previous 24 hours or urine toxicology screen positive for drugs of abuse 2) Overdose, within previous 24 hours, of any agent which would compromise ketamine metabolism 3) Symptoms of substance abuse/dependence(except nicotine dependence) within 6 months 4) Lifetime use of ketamine or phencyclidine(PCP) 5) Diagnosis of psychosis or bipolar disorder
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tung-Ping Su
Organization	CHENG HSIN GENERAL HOSPITAL
Division name	Department of Psychiatry
Zip code
Address	No.45,Cheng Hsin St.,Pai-Tou,Taipei
TEL	02-28264400
Email	tomsu0402@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Tung-Ping Su
Organization	CHENG HSIN GENERAL HOSPITAL
Division name	Department of Psychiatry
Zip code
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,TAIWAN
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
Address
Tel
Email

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	2018 Year 08 Month 15 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	2018 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 08 Month 15 Day
Last modified on	2019 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038444