UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	COMPARATIVE STUDY OF ESKETAMINE AND RACEMIC KETAMINE IN TREATMENT-RESISTANT DEPRESSION: A RANDOMIZED, DOUBLE-BLIND, NON-INFERIORITY TRIAL
Title of the study (Brief title)	COMPARATIVE STUDY OF ESKETAMINE AND RACEMIC KETAMINE IN TRD
Region	South America

Condition
Condition	Treatment Resistant Depression
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	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.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Esketamine
Interventions/Control_2	Racemic ketamine
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	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
Key exclusion criteria	-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.
Target sample size	68

Research contact person
Name of lead principal investigator	Lucas C. Quarantini
Organization	Universidade Federal da Bahia
Division name	Department of Psychiatry
Address	Rua Augusto Viana, SN, Canela, Salvador-BA, Brazil
TEL	+55-71-32838100
Email	quarantini@gmail.com

Public contact
Name of contact person	Fernanda Santana Correia de Melo
Organization	Universidade Federal da Bahia
Division name	Department of Psychiatry
Address	Rua Augusto Viana, SN, Canela, Salvador-BA, Brazil
TEL	557132838100
Homepage URL
Email	fernandascorreia@hotmail.com

Sponsor
Institute	HUPES - Hospital Universitario Professor Edgard Santos
Institute
Department

Funding Source
Organization	HUPES - Hospital Universitario Professor Edgard Santos
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Brazilian

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

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	2018 Year 05 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 10 Month 01 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 04 Month 24 Day
Last modified on	2018 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036902