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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02782104




Registration number
NCT02782104
Ethics application status
Date submitted
29/04/2016
Date registered
25/05/2016
Date last updated
28/05/2021

Titles & IDs
Public title
A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
Scientific title
An Open-label Long-term Extension Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
Secondary ID [1] 0 0
54135419TRD3008
Secondary ID [2] 0 0
CR108149
Universal Trial Number (UTN)
Trial acronym
SUSTAIN-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder, Treatment-Resistant 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Esketamine Nasal Spray

Experimental: Esketamine Nasal Spray - Open-Label Induction Phase: Participants will self-administer with esketamine nasal spray twice per week for 4 weeks as a flexible dose regimen (56 milligram [mg] or 84 mg for those < 65 years; 28 mg, 56 mg or 84 mg for those >= 65 years). Participants >= 65 years old will start at a dose of 28 mg on Day 1. Optimization/Maintenance Phase: Participants entering from studies ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868), ESKETINTRD3004 (NCT02497287), or ESKETINTRD3006 (US sites only) will self-administer esketamine nasal spray (same dose) once weekly. Participants entering from study ESKETINTRD3005 (NCT02422186) will self-administer esketamine nasal spray (28 mg in week 1; 28 or 56 mg in week 2; and 28, 56 or 84 mg in week 3 and 4) once weekly. After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants can be adjusted based upon efficacy and tolerability.


Treatment: Drugs: Esketamine Nasal Spray
Open-Label Induction Phase: Participants will self-administer with esketamine nasal spray twice per week for 4 weeks as a flexible dose regimen (56 milligram [mg] or 84 mg for those < 65 years; 28 mg, 56 mg or 84 mg for those >= 65 years). Participants >= 65 years old will start at a dose of 28 mg on Day 1. Optimization/Maintenance Phase: Participants entering from studies ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585) or ESKETINTRD3006 (US sites only) will self-administer esketamine nasal spray (same dose) once weekly. Participants entering from study ESKETINTRD3005 (NCT02422186) will self-administer esketamine nasal spray (28 mg in week 1; 28 or 56 mg in week 2; and 28, 56 or 84 mg in week 3 and 4) once weekly. After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants can be adjusted based upon efficacy and tolerability.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to End of Study (approximately 5 years 3 months)
Primary outcome [2] 0 0
Change From Baseline in Systolic and Diastolic Blood Pressure - Change From Baseline (predose) in systolic and diastolic blood pressure will be assessed.
Timepoint [2] 0 0
Baseline of each dosing session (predose) up to the last post-dose measurement from the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Primary outcome [3] 0 0
Change From Baseline in Heart Rate - Change from Baseline (predose) in heart rate will be assessed.
Timepoint [3] 0 0
Baseline of each dosing session (predose) up to the last post-dose measurement from the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Primary outcome [4] 0 0
Change From Baseline in Blood Oxygen Saturation - Change From Baseline in Blood oxygen saturation (predose) will be assessed.
Timepoint [4] 0 0
Baseline of each dosing session (predose) up to the last post-dose measurement from the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Primary outcome [5] 0 0
Change From Baseline in Modified Observer's Assessment of Alertness/Sedation (MOAAS) Scale Score - The MOAA/S will be used to measure treatment-emergent sedation, with correlation to levels of sedation defined by the American Society of Anesthesiologists (ASA) continuum.
The MOAA/S scores range from 0=no response to painful stimulus (corresponds to ASA continuum for general anesthesia) to 5=readily responds to name spoken in normal tone (awake; corresponds to ASA continuum for minimal sedation).
Timepoint [5] 0 0
1 hour post-dose from the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Primary outcome [6] 0 0
Change from Baseline in Electrocardiogram (ECG) intervals - Change From Baseline (predose) in Electrocardiogram (ECG) intervals will be assessed.
Timepoint [6] 0 0
Baseline of each dosing session (predose) up to the last post-dose measurement from the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Primary outcome [7] 0 0
Change From Baseline in Computerized Cognitive Battery Domain Score - The Change From Baseline in computerized cognitive battery will provide assessment of multiple cognitive domains, including attention, visual learning memory, and executive function.
Timepoint [7] 0 0
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Primary outcome [8] 0 0
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score - The HVLT-R is a measure of verbal learning and memory, is a 12-item word list recall test. Scores include learning, delayed recall, and recognition. The HVLT-R is a well-validated and widely used measure of verbal episodic memory.
Timepoint [8] 0 0
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Primary outcome [9] 0 0
Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score - Change from baseline in suicidal ideation or behavior measured using C-SSRS score will be reported. C-SSRS is a clinician rated assessment of suicidal behavior and / or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Timepoint [9] 0 0
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Primary outcome [10] 0 0
Changes From Baseline Over Time in Clinical Laboratory Tests
Timepoint [10] 0 0
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Primary outcome [11] 0 0
Time to Discharge Readiness Using the Clinical Global Assessment of Discharge Readiness (CGADR) - The CGADR will be used to measure the participant's current clinical status and is the clinician's assessment of the readiness to be discharged from the study site.
Timepoint [11] 0 0
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Secondary outcome [1] 0 0
Change From Baseline in Participant-Reported Depressive Symptoms Using the Patient Health Questionnaire - 9 (PHQ-9) Total Score - The PHQ-9 is a 9-item scale used to assess depressive symptoms. The responses for each item are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms.
Timepoint [1] 0 0
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Secondary outcome [2] 0 0
Change From Baseline in Clinical Global Impression-Severity (CGI-S) score - The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7.
Timepoint [2] 0 0
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Secondary outcome [3] 0 0
Change From Baseline in days when participants assess disruption of (1) work/school, (2) social life, leisure activities, and (3) family life/home responsibilities as Assessed by the Sheehan Disability Scale (SDS) Total Score - The SDS, a patient-reported outcome measure, is a 5 item questionnaire which has been widely used and accepted for assessment of functional and associated disability impairment. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items are summed to create a total score of 0-30 where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when underproductive.
Timepoint [3] 0 0
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Secondary outcome [4] 0 0
Change From Baseline in days symptoms caused participants to miss school or work or were unable to carry out normal daily responsibilitieswhen participant lost from school or work as as Assessed by the Sheehan Disability Scale (SDS) - The SDS, a patient-reported outcome measure, is a 5 item questionnaire which has been widely used and accepted for assessment of functional and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items are summed to create a total score of 0-30 where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when underproductive.
Timepoint [4] 0 0
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Secondary outcome [5] 0 0
Change From Baseline in days when participant was underproductive as Assessed by the Sheehan Disability Scale (SDS) - The SDS, a patient-reported outcome measure, is a 5 item questionnaire which has been widely used and accepted for assessment of functional and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items are summed to create a total score of 0-30 where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when underproductive.
Timepoint [5] 0 0
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Secondary outcome [6] 0 0
Change From Baseline in Participant-Reported Health-related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) ) Valuation Index Score - The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. EQ-5D scores include EQ-5D valuation index score (a weighted scoring of the 5 dimension scores with a possible range from 0 to 1) and EQ5D descriptive system scores (five scores reflecting each of the 5 EQ-5D health dimensions ranging from 0 [no limitation] to 4 [incapacity]).
Timepoint [6] 0 0
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Secondary outcome [7] 0 0
Change From Baseline in Participant-Reported Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Visual Analog Scale (VAS) - EQ-5D visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead.
Timepoint [7] 0 0
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Secondary outcome [8] 0 0
Change From Baseline in Participant- Reported Health Related Quality of Life Using the Quality of Life in Depression Scale (QLDS) - The QLDS is a disease specific PRO designed to assess health related quality of life in patients with Major Depressive Disorder. The instrument has a recall period of "at the moment", contains 34-items with "yes"/"no" response options and takes approximately 5-10 minutes to complete. The score range is from 0 (good quality of life) to 34 (very poor quality of life).
Timepoint [8] 0 0
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)

Eligibility
Key inclusion criteria
- Based on the prior study the participant is entering 54135419TRD3008 from: a) From
ESKETINTRD3001 (NCT02417064) or ESKETINTRD3002 (NCT02418585) study: Participant has
completed the induction phase and the 2-weeks follow up phase visit; or Participants
completed the induction phase and was a responder and study ESKETINTRD3003 is
terminated.; b) From ESKETINTRD3003 (NCT02493868) study: (1) Participant relapsed
during the maintenance phase; or (2) Participant was in the induction phase of the
ESKETINTRD3003 study when the study was terminated and, after completion of the
induction phase, was determined to be a responder; or (3) Participant was in the
optimization or maintenance phases at the time the study was terminated; or (4) or (5)
Participants was in the induction phase and after completion of induction phase was
determined to not meet response criteria (1) Participant completed ESKETINTRD3004
study (optimization/maintenance phase); or (2) Participant was in the induction phase
of the ESKETINTRD3004 study when the study was terminated and, after completion of the
induction phase, was determined to be a responder; or (3) Participant was in the
optimization/maintenance phase at the time the study was terminated; (4) Participant
was in the induction phase and did not meet criteria for response may be eligible for
to be rolled over into 54135419TRD3008. d) From ESKETINTRD3005 (NCT02422186) study:
Participant was in the induction phase of the ESKETINTRD3005 study at the time
enrollment into the ESKETINTRD3004 study was closed and, after completion of the
induction phase, was determined to be a responder or did not meet the criteria for
response. e) From ESKETINTRD3006 study (US Study sites only) (1) Participant completed
the induction phase and was a responder.

- Participant must be medically stable on the basis of physical examination, vital
signs, pulse oximetry, and 12-lead Electrocardiogram (ECG) performed predose on the
day of the first intranasal treatment session. If there are any abnormalities that are
not specified in the inclusion and exclusion criteria, their clinical significance
must be determined by the investigator and recorded in the participant's source
documents and initialed by the investigator

- Participant must be medically stable according to the investigator's judgment and
knowledge of the subject's medical stability in the parent study. This determination
must be documented.

- A woman of childbearing potential must have a negative serum (beta-human chorionic
gonadotropin [b-hCG]) predose on the day of the first intranasal treatment session

- During the study (that is, from the first intranasal treatment session) and for a
minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving
the last dose of intranasal study medication, a man who is sexually active with a
woman of childbearing potential must be practicing a highly effective method of
contraception with his female partner c) must agree not to donate sperm.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- The evaluation of the benefit versus risk of continued esketamine nasal spray
treatment is not favorable for the participant in the opinion of the investigator

- Since the last study visit in the participant's prior study, participant has suicidal
ideation with intent to act per the investigator's clinical judgment or based on the
Columbia Suicide Severity Rating Scale (C-SSRS) [corresponding to a response of "Yes"
on Item 4 (active suicidal ideation with some intent to act, without specific plan) or
Item 5 (active suicidal ideation with specific plan and intent) in the suicidal
ideation module of the C-SSRS] or suicidal behavior per the investigator's clinical
judgment or based on the C-SSRS (corresponding to any score higher than 0 in the
suicidal behavior module of the C-SSRS)

- Participant has positive test result(s) for drugs of abuse (including barbiturates,
methadone, opiates, cocaine, phencyclidine, and amphetamine/methamphetamine) predose
on the day of the first intranasal treatment session

- Participant has any anatomical or medical condition that, per the investigator's
clinical judgment based on assessment, may impede delivery or absorption of intranasal
study drug

- Participant has taken any prohibited therapies that would not permit administration of
the first intranasal treatment session

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Caulfield
Recruitment hospital [2] 0 0
- Elizabeth Vale
Recruitment hospital [3] 0 0
- Frankston
Recruitment postcode(s) [1] 0 0
- Caulfield
Recruitment postcode(s) [2] 0 0
- Elizabeth Vale
Recruitment postcode(s) [3] 0 0
- Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
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North Carolina
Country [18] 0 0
United States of America
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Ohio
Country [19] 0 0
United States of America
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Oklahoma
Country [20] 0 0
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Pennsylvania
Country [21] 0 0
United States of America
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Rhode Island
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
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Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Wisconsin
Country [26] 0 0
Argentina
State/province [26] 0 0
Banfield
Country [27] 0 0
Argentina
State/province [27] 0 0
Ciudad Autonoma de Buenos Aires
Country [28] 0 0
Argentina
State/province [28] 0 0
Ciudad Autónoma De Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Cordoba
Country [30] 0 0
Argentina
State/province [30] 0 0
La Plata
Country [31] 0 0
Argentina
State/province [31] 0 0
Mendoza
Country [32] 0 0
Argentina
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Rosario
Country [33] 0 0
Austria
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Vienna
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Belgium
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Aalst
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Belgium
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Brugge
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Belgium
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Brussel
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Belgium
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Heusden-Zolder
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Belgium
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Liège
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Belgium
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Yvoir
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Brazil
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Belo Horizonte
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Brazil
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Curitiba
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Brazil
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Fortaleza
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Brazil
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Recife
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Brazil
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Rio de Janeiro
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Brazil
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São Bernardo do Campo
Country [48] 0 0
Brazil
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São Paulo
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Bulgaria
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Bourgas
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Bulgaria
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Kardzhali
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Bulgaria
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Pazardzhik
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Rousse
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Canada
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British Columbia
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Canada
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Ontario
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Czechia
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Brno
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Czechia
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Plzen
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Czechia
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Prague
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Czechia
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Praha 10
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Czechia
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Praha 2
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Czechia
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Praha 6
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Estonia
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Tallinn
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Estonia
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Tartu
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Finland
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Kuopio
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France
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Clermont-Ferrand Cedex 1
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France
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Douai
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France
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Nantes
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France
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Nîmes
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France
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Paris
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France
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Poitiers Cedex
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France
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Toulon Cedex
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Mainz
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Germany
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Mittweida
Country [79] 0 0
Germany
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Oranienburg
Country [80] 0 0
Germany
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Pfaffenhofen
Country [81] 0 0
Hungary
State/province [81] 0 0
Budapest
Country [82] 0 0
Hungary
State/province [82] 0 0
Debrecen
Country [83] 0 0
Hungary
State/province [83] 0 0
Gyor
Country [84] 0 0
Hungary
State/province [84] 0 0
Pecs
Country [85] 0 0
Hungary
State/province [85] 0 0
Sopron
Country [86] 0 0
Hungary
State/province [86] 0 0
Szekszárd
Country [87] 0 0
Hungary
State/province [87] 0 0
Vác
Country [88] 0 0
Korea, Republic of
State/province [88] 0 0
Gwangju
Country [89] 0 0
Korea, Republic of
State/province [89] 0 0
Seoul
Country [90] 0 0
Lithuania
State/province [90] 0 0
Kaunas
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Malaysia
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Kuala Lumpur
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Mexico
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Guadalajara
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Mexico
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Leon
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Mexico
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Mexico City
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Mexico
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Mexico
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Mexico
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Monterrey
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Mexico
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San Luis Potosi
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Poland
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Belchatow
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Leszno
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Poland
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Lublin
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Poland
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Warszawa
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Slovakia
State/province [105] 0 0
Bratislava
Country [106] 0 0
Slovakia
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Liptovsky Mikulas
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Slovakia
State/province [107] 0 0
Rimavska Sobota
Country [108] 0 0
Slovakia
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety and tolerability of esketamine nasal spray
in participants with treatment-resistant depression (TRD).
Trial website
https://clinicaltrials.gov/show/NCT02782104
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications