UMIN-CTR Clinical Trial

Basic information
Public title	Using blood level measurement to gauge the targeting dose of Ketamine infusion in treatment refractory depression.
Acronym	Single Low-Dose Ketamine Injection in Treating Major Depression
Scientific Title	Using blood level measurement to gauge the targeting dose of Ketamine infusion in treatment refractory depression.
Scientific Title:Acronym	Single Low-Dose Ketamine Injection in Treating Major Depression
Region	Asia(except Japan)

Condition
Condition	Single Low-Dose Ketamine Injection in Treating Major Depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The optimal dose of intravenous ketamine for major depression in Chinese population
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The higher dose of intravenous ketamine needed for major depression in Chinese population
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Ketamine(0.8mg/kg)
Interventions/Control_2
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	1.Diagnosis of major depressive disorder. 2.Voluntary patients with signed informed consent proved by institutional review board (IRB) 3.Age>=20y/o<65 y/o
Key exclusion criteria	1.Major medical conditions (e.g., head injury, epilepsy, severe renal and cancer). 2.Pregnancy 3.Use of CNS intoxicant (eq. cocaine, cannabis, opiates) within the previous 24 hours. 4.Symptoms of substance abuse/dependence(except nicotine dependence) within 6 months 5.Lifetime use of ketamine or phencyclidine (PCP) 6.Diagnosis of psychosis or bipolar disorder 7.current NMDA antagonist medication (eq. Amantadine, Rimantadine, Lamotrigine, Memantine, Dextromethorphan) 8.Actively trying to commit suicide even in a hospital setting 9.Current homicide risk
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mu-Hong Chen
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	+886-2-28757027
Email	kremer7119@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Mu-Hong Chen
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	+886-2-28757027
Homepage URL
Email	kremer7119@gmail.com

Sponsor
Institute	Taipei Veterans General Hospital
Institute
Department

Funding Source
Organization	Taipei Veterans 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
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

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 31 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	2016 Year 01 Month 01 Day
Date of IRB	2016 Year 01 Month 29 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 11 Month 01 Day
Date trial data considered complete	2016 Year 11 Month 30 Day
Date analysis concluded	2016 Year 12 Month 30 Day

Other
Other related information

Management information
Registered date	2016 Year 08 Month 10 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=R000027158