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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02782104
Ethics application status
Date submitted
29/04/2016
Date registered
25/05/2016
Date last updated
20/02/2024

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
Change From Study Baseline in Computerized Cognitive Battery Domain Score: Detection Test (DET) Score
Timepoint [1] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Primary outcome [2] 0 0
Change From Study Baseline in Computerized Cognitive Battery Domain Score: Identification Test (IDN) Score
Timepoint [2] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Primary outcome [3] 0 0
Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Card Learning Test (OCL) Score
Timepoint [3] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Primary outcome [4] 0 0
Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Back Test (ONB) Score
Timepoint [4] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Primary outcome [5] 0 0
Change From Study Baseline in Computerized Cognitive Battery Domain Score: Groton Maze Learning Test (GMLT) Score
Timepoint [5] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Primary outcome [6] 0 0
Change From Study Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score
Timepoint [6] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Primary outcome [7] 0 0
Percentage of Participants Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Timepoint [7] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Primary outcome [8] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [8] 0 0
IND Phase: up to 4 weeks; OP/MA Phase: up to 78 months
Primary outcome [9] 0 0
Change From Baseline in Heart Rate
Timepoint [9] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Primary outcome [10] 0 0
Change From Baseline in Systolic and Diastolic Blood Pressure
Timepoint [10] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Primary outcome [11] 0 0
Change From Baseline in Respiratory Rate
Timepoint [11] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Primary outcome [12] 0 0
Change From Baseline in Blood Oxygen Saturation
Timepoint [12] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Secondary outcome [1] 0 0
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Timepoint [1] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Secondary outcome [2] 0 0
Change From Baseline in Participant-Reported Depressive Symptoms Using the Patient Health Questionnaire - 9 (PHQ-9) Total Score
Timepoint [2] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Secondary outcome [3] 0 0
Change From Baseline in Clinical Global Impression-severity (CGI-S) Score
Timepoint [3] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Secondary outcome [4] 0 0
Change From Baseline in Sheehan Disability Scale (SDS) Total Score
Timepoint [4] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Secondary outcome [5] 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 (VAS)
Timepoint [5] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Secondary outcome [6] 0 0
Change From Baseline as Assessed by EQ 5D-5L: Sum Score
Timepoint [6] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Secondary outcome [7] 0 0
Change From Baseline in Participant- Reported Health Related Quality of Life Using the Quality of Life in Depression Scale (QLDS)
Timepoint [7] 0 0
IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 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
Sex
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
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
9/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/12/2022
Sample size
Target
Accrual to date
Final
1148
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
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Kaohsiung
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Taiwan
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Taoyuan
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Turkey
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Adana
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Ankara
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Bursa
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Istanbul
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Turkey
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Kucukcekmece/Istanbul
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Turkey
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Oanakkale
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Turkey
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Samsun
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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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Northampton
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United Kingdom
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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/study/NCT02782104
Trial related presentations / publications
Starr HL, Abell J, Larish A, Lewis S, DeMuro C, Gogate J, Jamieson C, Daly E, Zaki N, Kramer M. Self-reported review of the value of esketamine in patients with treatment-resistant depression: Understanding the patient experience in the STRIVE Study. Psychiatry Res. 2020 Nov;293:113376. doi: 10.1016/j.psychres.2020.113376. Epub 2020 Aug 8.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02782104