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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038347
Receipt No. R000043702
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
Date of disclosure of the study information 2019/10/21
Last modified on 2019/10/22

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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 Open public recruiting
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
2020 Year 12 Month 31 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
2019 Year 10 Month 22 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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