Unique ID issued by UMIN | UMIN000038347 |
---|---|
Receipt number | 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 | 2022/02/10 09:32:52 |
Effects of single intravenous arketamine dose as an adjunctive therapy for treatment-resistant unipolar depression: a randomized, double-blind, crossover, placebo-controlled trial
The ARKETP study
Effects of single intravenous arketamine dose as an adjunctive therapy for treatment-resistant unipolar depression: a randomized, double-blind, crossover, placebo-controlled trial
The ARKETP study
South America |
Unipolar depression
Psychiatry |
Others
NO
To evaluate whether arketamine produces rapid antidepressive effects in patients with treatment-resistant unipolar depression
Safety,Efficacy
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).
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine |
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.
Placebo
18 | years-old | <= |
65 | years-old | >= |
Male and Female
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.
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.
10
1st name | Lucas |
Middle name | C |
Last name | Quarantini |
Federal University of Bahia
Laboratory of Neuropsychopharmacology
40110060
R. Dr. Augusto Viana, S/n - Canela
557132838076
lcq@ufba.br
1st name | Lucas |
Middle name | C |
Last name | Quarantini |
Federal University of Bahia
Laboratory of Neuropsychopharmacology
40110060
R. Dr. Augusto Viana, S/n - Canela
557132838076
lcq@ufba.br
Federal University of Bahia
Fundacao de Amparo a Pesquisa do Estado da Bahia
Non profit foundation
Professor Edgard Santos University Hospital
R. Dr. Augusto Viana, S/n - Canela
557132838043
cep.hupes@gmail.com
NO
2019 | Year | 10 | Month | 21 | Day |
Unpublished
Completed
2019 | Year | 08 | Month | 20 | Day |
2019 | Year | 06 | Month | 28 | Day |
2019 | Year | 08 | Month | 20 | Day |
2021 | Year | 12 | Month | 20 | Day |
2019 | Year | 10 | Month | 21 | Day |
2022 | Year | 02 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043702