UMIN-CTR Clinical Trial

Basic information
Public title	Effects of single intravenous arketamine dose as an adjunctive therapy for treatment-resistant unipolar depression: a randomized, double-blind, crossover, placebo-controlled trial
Acronym	The ARKETP study
Scientific Title	Effects of single intravenous arketamine dose as an adjunctive therapy for treatment-resistant unipolar depression: a randomized, double-blind, crossover, placebo-controlled trial
Scientific Title:Acronym	The ARKETP study
Region	South America

Condition
Condition	Unipolar depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether arketamine produces rapid antidepressive effects in patients with treatment-resistant unipolar depression
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint will be a change in the overall MADRS score from day 1 (baseline) to day 2 (24 hours after the first infusion).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A pilot study will be conducted with patients with unipolar depression at a dose of 0.5mg / kg. Afterwards, the randomized, double-blind, crossover, controlled study will be performed. (R)-ketamine / placebo: patients will receive a single dose of (R)-ketamine or placebo, administered intravenously for 40 minutes. Afterwards, patients will receive another dose of the study drug cross-linked; that is, those who previously used (R)-ketamine will be switched to placebo, and those who receive placebo will be transferred to the active group. Pulse oximetry, heart rate, and blood pressure will be measured continuously from 15 minutes before each dose to 4 hours after each dose of arketamine or placebo to monitor safety. No patient will be released from the study protocol without all the measures necessary to ensure their safety being taken.
Interventions/Control_2	Placebo
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	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Both genders; age between 18 to 65 years; subjects must fulfill Diagnostic and Statistical Manual of Mental Disorders 5th Edition criteria for Major Depressive Disorder, without psychotic features; initial score of at least 25 on the Montgomery Asberg Depression Rating Scale at study baseline; subjects must, at some point in their past, have failed to respond to an adequate dose and duration of at least two antidepressant trial during a current depressive episode; current depressive episode of at least 4 weeks duration.
Key exclusion criteria	Current or past diagnosis of Schizophrenia or any other psychotic disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition; subjects with a history of substance abuse disorder, according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition, within the previous 3 months; female subjects who are either pregnant or breastfeeding; serious, unstable medical illnesses; history of seizures without a clear and resolved etiology; treatment with a monoamine oxidase inhibitors within the 4 weeks prior to study; treatment with any other concomitant medication that has been disallowed; presence of any medical illness likely to alter brain morphology and/or physiology; clinically significant abnormal laboratory tests; intellectual disabilities.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Lucas Middle name C Last name Quarantini
Organization	Federal University of Bahia
Division name	Laboratory of Neuropsychopharmacology
Zip code	40110060
Address	R. Dr. Augusto Viana, S/n - Canela
TEL	557132838076
Email	lcq@ufba.br

Public contact
Name of contact person	1st name Lucas Middle name C Last name Quarantini
Organization	Federal University of Bahia
Division name	Laboratory of Neuropsychopharmacology
Zip code	40110060
Address	R. Dr. Augusto Viana, S/n - Canela
TEL	557132838076
Homepage URL
Email	lcq@ufba.br

Sponsor
Institute	Federal University of Bahia
Institute
Department

Funding Source
Organization	Fundacao de Amparo a Pesquisa do Estado da Bahia
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Professor Edgard Santos University Hospital
Address	R. Dr. Augusto Viana, S/n - Canela
Tel	557132838043
Email	cep.hupes@gmail.com

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	2019 Year 10 Month 21 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	2019 Year 08 Month 20 Day
Date of IRB	2019 Year 06 Month 28 Day
Anticipated trial start date	2019 Year 08 Month 20 Day
Last follow-up date	2021 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 21 Day
Last modified on	2022 Year 02 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043702