UMIN-CTR Clinical Trial

Basic information
Public title	Fast Antidepressant Efficacy and Central Mechanisms of Single Low-Dose Ketamine Injection in Treating Major Depression: a double-blind and randomized-controlled trial and image study
Acronym	Single Low-Dose Ketamine Injection in Treating Major Depression
Scientific Title	Fast Antidepressant Efficacy and Central Mechanisms of Single Low-Dose Ketamine Injection in Treating Major Depression: a double-blind and randomized-controlled trial and image study
Scientific Title:Acronym	Single Low-Dose Ketamine Injection in Treating Major Depression
Region	Asia(except Japan)

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

Objectives
Narrative objectives1	the project combined with image studies to study the specific antidepressant mechanisms of ketamine.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PET MRI MADRS
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	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ketamine 0.5mg/kg
Interventions/Control_2	Ketamine 0.2mg/kg
Interventions/Control_3	PBO
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	72

Research contact person
Name of lead principal investigator	1st name Middle name Last name Cheng-Ta Li
Organization	Taipei Veterans General Hospital,Taiwan
Division name	Psychiatry Department
Zip code
Address	No.201, Sec.2, Shih-Pai Rd, Beitou district, Taipei, Taiwan
TEL	+81-1886228757027
Email	on5083@msn.com

Public contact
Name of contact person	1st name Middle name Last name Cheng-Ta Li
Organization	Taipei Veterans General Hospital
Division name	Psychiatry
Zip code
Address	No.201, Sec.2, Shih-Pai Road, Beitou district
TEL	+81-1886228757027
Homepage URL
Email	on5083@msn.com

Sponsor
Institute	Ministry of Science and Technology
Institute
Department

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
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	Taipei Veterans General Hospital(Taiwan)

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 30 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	Completed
Date of protocol fixation	2012 Year 12 Month 01 Day
Date of IRB	2012 Year 06 Month 13 Day
Anticipated trial start date	2014 Year 12 Month 31 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 30 Day
Date trial data considered complete	2016 Year 04 Month 30 Day
Date analysis concluded	2016 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2015 Year 03 Month 31 Day
Last modified on	2021 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019001