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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02497287




Registration number
NCT02497287
Ethics application status
Date submitted
18/05/2015
Date registered
14/07/2015
Date last updated
6/05/2020

Titles & IDs
Public title
A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression
Scientific title
An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression
Secondary ID [1] 0 0
ESKETINTRD3004
Secondary ID [2] 0 0
CR107148
Universal Trial Number (UTN)
Trial acronym
SUSTAIN-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment-resistant Depression 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 (Intranasal Spray)
Treatment: Drugs - Duloxetine (Oral Antidepressant)
Treatment: Drugs - Escitalopram (Oral Antidepressant)
Treatment: Drugs - Sertraline (Oral Antidepressant)
Treatment: Drugs - Venlafaxine Extended Release (XR) (Oral Antidepressant)

Experimental: Intranasal Esketamine plus oral antidepressant - Open-Label Induction Phase: Participants will self-administer esketamine intranasally twice per week for 4 weeks as a flexible dose regimen (56 mg or 84 mg). Participants greater than or equal to (\>=) 65 will start at a dose of 28 mg on Day 1. Direct-entry participants will initiate a new, open-label oral antidepressant (duloxetine, escitalopram, sertraline, or venlafaxine extended release \[XR\]) on Day 1; transferred-entry participants will continue the same oral antidepressant from ESKETINTRD3005. Optimization/Maintenance Phase: Participants will self-administer esketamine (56mg or 84mg for those \< 65 years; 28 mg, 56 mg or 84 mg for those \>= 65 years) intranasally once per week for 4 weeks; transferred entry responder subjects from ESKETINTRD3005 will start at a dose of 28 mg in the first week. All participants will continue their same oral antidepressant during this phase.


Treatment: Drugs: Esketamine (Intranasal Spray)
Open-Label Induction Phase: Participants will self-administer esketamine intranasally twice per week for 4 weeks as a flexible dose regimen (56 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 will self-administer esketamine intranasally (56 mg or 84 mg for those \< 65 years; 28 mg, 56 mg or 84 mg for those \>= 65 years) once weekly then individualized to either once weekly or once every other week based on the severity of depressive symptoms. Transferred-entry responder participants from ESKETINTRD3005 \>= 65 years old will start at a dose of 28 mg in Week 5.

Treatment: Drugs: Duloxetine (Oral Antidepressant)
Duloxetine could be selected as the oral antidepressant medication by the investigator based on review of Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and relevant prior antidepressant medication information. The minimum therapeutic dose is 60 milligram per day (mg/day).

Treatment: Drugs: Escitalopram (Oral Antidepressant)
Escitalopram could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. The minimum therapeutic dose is 10 mg/day. Participants \>= 65 years of age will be titrated up to 20 mg/day, but can lower the dose to 10 mg/day for tolerability.

Treatment: Drugs: Sertraline (Oral Antidepressant)
Sertraline could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Sertraline will be titrated up to a dose of 150 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 50 mg/day.

Treatment: Drugs: Venlafaxine Extended Release (XR) (Oral Antidepressant)
Venlafaxine Extended Release could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Venlafaxine Extended Release will be titrated for participants \< 65 years of age up to a dose of 225 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 150 mg/day. For participants \>= 65, it can be titrated up to a dose of 150 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 75 mg/day.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to End of Follow up Phase (Week 56)
Primary outcome [2] 0 0
Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders
Timepoint [2] 0 0
Up to End of Follow up Phase (Week 56)
Primary outcome [3] 0 0
Change From Baseline in Cognitive Test Battery: Detection Test (DET) Score
Timepoint [3] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of Optimization/Maintenance [OP/MA] Phase)
Primary outcome [4] 0 0
Change From Baseline in Cognitive Test Battery: Identification Test (IDN) Score
Timepoint [4] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Primary outcome [5] 0 0
Change From Baseline in Cognitive Test Battery: One Card Learning Test (OCL) Score
Timepoint [5] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Primary outcome [6] 0 0
Change From Baseline in Cognitive Test Battery: One Back Test (ONB) Score
Timepoint [6] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Primary outcome [7] 0 0
Change From Baseline in Cognitive Test Battery: Groton Maze Learning Test (GMLT) Score
Timepoint [7] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Primary outcome [8] 0 0
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Total Recall
Timepoint [8] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Primary outcome [9] 0 0
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Delayed Recall
Timepoint [9] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Primary outcome [10] 0 0
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Number of Words Recalled
Timepoint [10] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Primary outcome [11] 0 0
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Recognition Discrimination Index
Timepoint [11] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Secondary outcome [1] 0 0
Change From Baseline to Endpoint in Montgomery Asberg Depression Rating Scale (MADRS) Total Score During Induction (IND) Phase
Timepoint [1] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Secondary outcome [2] 0 0
Change From Baseline to Endpoint in MADRS Total Score During Optimization/Maintenance (OP/MA) Phase
Timepoint [2] 0 0
Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
Secondary outcome [3] 0 0
Change From Baseline to Endpoint in Patient Health Questionnaire - 9 (PHQ-9) Total Score During IND Phase
Timepoint [3] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Secondary outcome [4] 0 0
Change From Baseline to Endpoint in PHQ-9 Total Score During OP/MA Phase
Timepoint [4] 0 0
Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Secondary outcome [5] 0 0
Change From Baseline to Endpoint in Clinical Global Impression of Severity (CGI-S) Scale Score During IND Phase
Timepoint [5] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Secondary outcome [6] 0 0
Change From Baseline to Endpoint in CGI-S Scale Score During OP/MA Phase
Timepoint [6] 0 0
Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Secondary outcome [7] 0 0
Change From Baseline to Endpoint in Generalized Anxiety Disorder (GAD-7) Total Score During IND Phase
Timepoint [7] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Secondary outcome [8] 0 0
Change From Baseline to Endpoint in GAD-7 Total Score During OP/MA Phase
Timepoint [8] 0 0
Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Secondary outcome [9] 0 0
Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During IND Phase: Sum Score
Timepoint [9] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Secondary outcome [10] 0 0
Change From Baseline to Endpoint in EQ-5D-5L Score During IND Phase: EQ-VAS
Timepoint [10] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Secondary outcome [11] 0 0
Change From Baseline to Endpoint in EQ-5D-5L Scale Score During IND Phase: Health Status Index
Timepoint [11] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Secondary outcome [12] 0 0
Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During OP/MA Phase: Sum Score
Timepoint [12] 0 0
Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Secondary outcome [13] 0 0
Change From Baseline to Endpoint in EQ-5D-5L Score During OP/MA Phase: EQ-VAS
Timepoint [13] 0 0
Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Secondary outcome [14] 0 0
Change From Baseline to Endpoint in EQ-5D-5L Scale Score During OP/MA Phase: Health Status Index
Timepoint [14] 0 0
Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Secondary outcome [15] 0 0
Change From Baseline in Sheehan Disability Scale (SDS) Total Score During IND Phase
Timepoint [15] 0 0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND Phase)
Secondary outcome [16] 0 0
Change From Baseline in Sheehan Disability Scale Total Score During OP/MA Phase
Timepoint [16] 0 0
Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
Secondary outcome [17] 0 0
Percentage of Participants With Response as Assessed by MADRS Total Score During IND Phase
Timepoint [17] 0 0
Days 8, 15, 22 and Endpoint (last post-baseline assessment during 4 weeks of IND phase)
Secondary outcome [18] 0 0
Percentage of Participants With Response as Assessed by PHQ-9 Total Score During IND Phase
Timepoint [18] 0 0
Day 15 and Endpoint (last post-baseline assessment value during 4 Week IND phase)
Secondary outcome [19] 0 0
Percentage of Participants With Remission as Assessed by MADRS Total Score During IND Phase
Timepoint [19] 0 0
Days 8, 15, 22 and Endpoint (last post-baseline assessment value during 4 weeks of IND Phase)
Secondary outcome [20] 0 0
Percentage of Participants With Remission as Assessed by PHQ-9 Total Score During IND Phase
Timepoint [20] 0 0
Day 15 and Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Secondary outcome [21] 0 0
Percentage of Participants With an Increase Score From Predose at Any Time in Clinician-Administered Dissociative States Scale (CADSS) Total Score During IND Phase
Timepoint [21] 0 0
Predose, up to 1.5 hours postdose (up to end of IND phase [Week 4])
Secondary outcome [22] 0 0
Percentage of Participants With an Increase Score From Predose at Any Time in CADSS Total Score During OP/MA Phase
Timepoint [22] 0 0
Predose, up to 1.5 hours postdose (up to end of OP/MA phase [Week 52])
Secondary outcome [23] 0 0
Percentage of Participants With Treatment-Emergent Acute Hypertension (Systolic and Diastolic) During IND and OP/MA Phases
Timepoint [23] 0 0
Up to End of OP/MA phase (Week 52)

Eligibility
Key inclusion criteria
A). For Direct-Entry Participants

* At the time of signing the informed consent form (ICF), participant must be a man or woman =18 (or older if the minimum legal age of consent in the country in which the study is taking place is greater than [>]18)
* At the start of the screening phase, participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) (if single-episode MDD, the duration must be greater than or equal to [>=] 2 years) or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the Mini-International Neuropsychiatric Interview (MINI)
* At screening, participant must have a MADRS total score of >=22
* At the start of the screening phase, participants must have had nonresponse to >=2 oral antidepressant treatments in the current episode of depression, as assessed using the the MGHATRQ and confirmed by documented records (example medical/pharmacy/prescription records or a letter from treating a physician, etc,) B). For Transferred-entry Participants
* All participants who completed the double-blind induction phase of ESKETINTRD3005 study, regardless of their response status, will be eligible to participate in this study, if they meet the study specific eligibility criteria
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A). For Direct-Entry Participants

* Participant's depressive symptoms have previously not responded to: Esketamine or ketamine in the current major depressive episode per clinical judgment or All of the 4 oral antidepressant treatment options available in the respective country for the open-label induction phase (that is, duloxetine, escitalopram, sertraline, and venlafaxine XR) in the current major depressive episode (based on Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire [ MGH-ATRQ])
* Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychotic features, bipolar or related disorders (confirmed by the MINI), obsessive compulsive disorder (current only), intellectual disability (DSM-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder
* Participant has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening phase, per the investigator's clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS)
* Participants with history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria
* Participants who has a Mini Mental State Examination (MMSE) <25; Has neurodegenerative disorder (example, Alzheimer's disease, vascular dementia, Parkinson's disease), or evidence of mild cognitive impairment (MCI) B). Transferred-Entry Participants
* Participant has taken any prohibited therapies that would not permit dosing on Day 1

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/10/2017
Sample size
Target
Accrual to date
Final
802
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Caulfield
Recruitment hospital [3] 0 0
- Frankston
Recruitment hospital [4] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Caulfield
Recruitment postcode(s) [3] 0 0
- Frankston
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
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United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
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Iowa
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United States of America
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Kansas
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United States of America
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Maryland
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United States of America
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Massachusetts
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New York
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Ohio
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Pennsylvania
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South Carolina
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Banfield
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Cordoba
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Argentina
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La Plata
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Mendoza
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Argentina
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Rosario
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Austria
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Innsbruck
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Vienna
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Brugge
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Belgium
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Hasselt
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Brazil
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Belo Horizonte
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Brazil
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Fortaleza
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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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Santo André
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Brazil
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São José do Rio Preto
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São Paulo
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Pleven
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Rousse
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Sofia
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TOURS cedex 9
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Lund
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Skovde
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Solna
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Stockholm
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Sweden
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Umea
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei City
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan County
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Turkey
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Ankara
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Turkey
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Bursa
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Gaziantep
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Turkey
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Istanbul
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Turkey
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Kocaeli
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Turkey
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Manisa
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United Kingdom
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Bristol
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United Kingdom
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Chesterfield
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United Kingdom
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Derby
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United Kingdom
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London
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United Kingdom
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Middlesbrough
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United Kingdom
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Northampton
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United Kingdom
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Oxford
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United Kingdom
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Preston

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 open-label, multicenter study is to assess the long term safety and efficacy of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression (TRD).
Trial website
https://clinicaltrials.gov/study/NCT02497287
Trial related presentations / publications
Williamson DJ, Gogate JP, Kern Sliwa JK, Manera LS, Preskorn SH, Winokur A, Starr HL, Daly EJ. Longitudinal Course of Adverse Events With Esketamine Nasal Spray: A Post Hoc Analysis of Pooled Data From Phase 3 Trials in Patients With Treatment-Resistant Depression. J Clin Psychiatry. 2022 Sep 19;83(6):21m14318. doi: 10.4088/JCP.21m14318.
Ochs-Ross R, Wajs E, Daly EJ, Zhang Y, Lane R, Lim P, Drevets WC, Steffens DC, Sanacora G, Jamieson C, Hough D, Manji H, Singh JB. Comparison of Long-Term Efficacy and Safety of Esketamine Nasal Spray Plus Oral Antidepressant in Younger Versus Older Patients With Treatment-Resistant Depression: Post-Hoc Analysis of SUSTAIN-2, a Long-Term Open-Label Phase 3 Safety and Efficacy Study. Am J Geriatr Psychiatry. 2022 May;30(5):541-556. doi: 10.1016/j.jagp.2021.09.014. Epub 2021 Oct 6.
Wajs E, Aluisio L, Holder R, Daly EJ, Lane R, Lim P, George JE, Morrison RL, Sanacora G, Young AH, Kasper S, Sulaiman AH, Li CT, Paik JW, Manji H, Hough D, Grunfeld J, Jeon HJ, Wilkinson ST, Drevets WC, Singh JB. Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression: Assessment of Long-Term Safety in a Phase 3, Open-Label Study (SUSTAIN-2). J Clin Psychiatry. 2020 Apr 28;81(3):19m12891. doi: 10.4088/JCP.19m12891.
Nijs M, Wajs E, Aluisio L, Turkoz I, Daly E, Janik A, Borentain S, Singh JB, DiBernardo A, Wiegand F. Managing Esketamine Treatment Frequency Toward Successful Outcomes: Analysis of Phase 3 Data. Int J Neuropsychopharmacol. 2020 Jul 29;23(7):426-433. doi: 10.1093/ijnp/pyaa027.
Public notes

Contacts
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Janssen Research & Development, LLC Clinical Trial
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Janssen Research & Development, LLC
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02497287