Unique ID issued by UMIN | UMIN000032355 |
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Receipt number | R000036902 |
Scientific Title | COMPARATIVE STUDY OF ESKETAMINE AND RACEMIC KETAMINE IN TREATMENT-RESISTANT DEPRESSION: A RANDOMIZED, DOUBLE-BLIND, NON-INFERIORITY TRIAL |
Date of disclosure of the study information | 2018/05/01 |
Last modified on | 2018/04/24 06:40:03 |
COMPARATIVE STUDY OF ESKETAMINE AND RACEMIC KETAMINE IN TREATMENT-RESISTANT DEPRESSION: A RANDOMIZED, DOUBLE-BLIND, NON-INFERIORITY TRIAL
COMPARATIVE STUDY OF ESKETAMINE AND RACEMIC KETAMINE IN TRD
COMPARATIVE STUDY OF ESKETAMINE AND RACEMIC KETAMINE IN TREATMENT-RESISTANT DEPRESSION: A RANDOMIZED, DOUBLE-BLIND, NON-INFERIORITY TRIAL
COMPARATIVE STUDY OF ESKETAMINE AND RACEMIC KETAMINE IN TRD
South America |
Treatment Resistant Depression
Psychiatry | Adult |
Others
NO
Our main objective is to determine if esketamine in noninferior to ketamine racemic mixture in terms of symptom remission in individuals with TRD.
Our secondary objectives are to compare individuals who have been submitted to treatment with esketamine or ketamine racemate in terms of:
Response of depressive symptoms
Tolerability and clinical safety
Dissociative / confusional symptoms during and immediately after infusion
Cognitive disturbance or improvement
Manic and hypomanic symptoms
Impact on suicidal behavior
Personality traits
Metabolomic profile and the changes in specific metabolites
Efficacy
Exploratory
Phase II
The primary outcome will be the difference in remission rates of depressive symptoms between the two treatment arms at 24 and 72 hours. Remission is defined as a MADRS score of 7 or less.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Esketamine
Racemic ketamine
18 | years-old | <= |
80 | years-old | >= |
Male and Female
All volunteers enrolled in the study must comply with all of the following at the time of the randomization:
-Have the diagnosis of MDD confirmed by the Brazilian version of the Mini International Neuropsychiatric Interview 5.0.0 (MINI-Plus) (Amorim, 2000) applied by experienced and properly trained evaluators.
-Be diagnosed with TRD, characterized by therapeutic failure after at least one adequate antidepressant treatment for at least 12 weeks.
-Be 18 years or older
-Patients who have been submitted to ECT
-Diagnosis of a psychotic disorder
-Mental retardation or dementia (except for patients with such diagnoses who have a family member or a responsible person who may sign their informed consent form)
-Decompensated heart disease
-Illicit drug users.
68
1st name | |
Middle name | |
Last name | Lucas C. Quarantini |
Universidade Federal da Bahia
Department of Psychiatry
Rua Augusto Viana, SN, Canela, Salvador-BA, Brazil
+55-71-32838100
quarantini@gmail.com
1st name | |
Middle name | |
Last name | Fernanda Santana Correia de Melo |
Universidade Federal da Bahia
Department of Psychiatry
Rua Augusto Viana, SN, Canela, Salvador-BA, Brazil
557132838100
fernandascorreia@hotmail.com
HUPES - Hospital Universitario Professor Edgard Santos
HUPES - Hospital Universitario Professor Edgard Santos
Government offices of other countries
Brazilian
NO
2018 | Year | 05 | Month | 01 | Day |
Unpublished
Open public recruiting
2016 | Year | 10 | Month | 01 | Day |
2017 | Year | 01 | Month | 01 | Day |
2018 | Year | 04 | Month | 24 | Day |
2018 | Year | 04 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036902
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