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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression
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Secondary ID [1]
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ESKETINTRD3004
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Secondary ID [2]
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CR107148
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Universal Trial Number (UTN)
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Trial acronym
SUSTAIN-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Treatment-resistant Depression
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [1]
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An adverse event is any untoward medical occurrence in a clinical study participants who administered a medicinal (investigational or non-investigational) product and does not necessarily have a causal relationship with the treatment. A TEAE defined as an event that was new in onset or increased in severity following treatment initiation.
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Timepoint [1]
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Up to End of Follow up Phase (Week 56)
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Primary outcome [2]
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Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders
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Assessment method [2]
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Percentage of participants with cystitis, urinary tract infections, renal and urinary tract symptoms, renal and urinary disorders were evaluated. Cystitis and urinary tract infections are selected MedDRA preferred terms, "renal and urinary tract symptoms" refers to any preferred term (PT) in the group of selected PTs; and "renal and urinary disorders" refers to a MedDRA System Organ Class (SOC).
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Timepoint [2]
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Up to End of Follow up Phase (Week 56)
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Primary outcome [3]
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Change From Baseline in Cognitive Test Battery: Detection Test (DET) Score
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Assessment method [3]
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This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. The DET is a measure of psychomotor function and uses a well-validated simple reaction time. In this outcome measure, speed of performance of participants (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Total score ranges from 2 to 3.3 log 10 milliseconds (msec). Lower score indicates better performance. Higher change from baseline indicates better performance.
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Timepoint [3]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of Optimization/Maintenance [OP/MA] Phase)
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Primary outcome [4]
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Change From Baseline in Cognitive Test Battery: Identification Test (IDN) Score
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Assessment method [4]
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This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. IDN test is a measure of visual attention (choice reaction time) and scored for speed of response (mean of the log10 transformed reaction times for correct responses). Total score ranges from 2 to 3.3 log 10 msec. Lower score indicates better performance. Higher change from baseline indicates better performance.
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Timepoint [4]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
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Primary outcome [5]
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Change From Baseline in Cognitive Test Battery: One Card Learning Test (OCL) Score
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Assessment method [5]
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This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. OCL test is a measure of visual episodic memory and visual recall test scored using arcsine transformation of the percentage of correct responses (CR). The range for OCL is 0 to 100 percent (%) accuracy; presented as an arcsin transformation, the range is 0 to 1.57. Higher score indicates better performance. Higher change from baseline indicates better performance.
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Timepoint [5]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
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Primary outcome [6]
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Change From Baseline in Cognitive Test Battery: One Back Test (ONB) Score
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Assessment method [6]
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The ONB is a measure of working memory and scored for speed of correct response (mean of the log10-transformed reaction times for correct responses). Total score ranges from 2 to 3.54 log10 msec. Lower score indicates better performance. Higher change from baseline indicates better performance.
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Timepoint [6]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
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Primary outcome [7]
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Change From Baseline in Cognitive Test Battery: Groton Maze Learning Test (GMLT) Score
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Assessment method [7]
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This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. GMLT measures executive function; maze/sequencing test, scored for total number of errors. Total score ranges from 0 to 999 number of errors. Lower score indicates better performance. Higher change from baseline indicates better performance.
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Timepoint [7]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
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Primary outcome [8]
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Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Total Recall
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Assessment method [8]
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Hopkins Verbal Learning Test (HVLT) measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.
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Timepoint [8]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
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Primary outcome [9]
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Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Delayed Recall
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Assessment method [9]
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HVLT measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.
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Timepoint [9]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
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Primary outcome [10]
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Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Number of Words Recalled
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Assessment method [10]
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HVLT measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.
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Timepoint [10]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
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Primary outcome [11]
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Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Recognition Discrimination Index
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Assessment method [11]
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HVLT measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.
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Timepoint [11]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
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Secondary outcome [1]
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Change From Baseline to Endpoint in Montgomery Asberg Depression Rating Scale (MADRS) Total Score During Induction (IND) Phase
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Assessment method [1]
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MADRS measures depression severity, detects changes due to AD treatment. It consists 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe condition. Negative change in score indicates improvement. Missing data was imputed using last observation carried forward (LOCF) method, last post baseline observation during the phase was carried forward as the "Endpoint".
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Timepoint [1]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
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Secondary outcome [2]
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Change From Baseline to Endpoint in MADRS Total Score During Optimization/Maintenance (OP/MA) Phase
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Assessment method [2]
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MADRS measure depression severity, detects changes due to AD treatment. It evaluates 10 items: apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the "Endpoint".
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Timepoint [2]
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Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)
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Secondary outcome [3]
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Change From Baseline to Endpoint in Patient Health Questionnaire - 9 (PHQ-9) Total Score During IND Phase
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Assessment method [3]
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PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. A higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the "Endpoint".
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Timepoint [3]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
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Secondary outcome [4]
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Change From Baseline to Endpoint in PHQ-9 Total Score During OP/MA Phase
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Assessment method [4]
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PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. A higher score indicates greater severity of depression. severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the "Endpoint".
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Timepoint [4]
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Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
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Secondary outcome [5]
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Change From Baseline to Endpoint in Clinical Global Impression of Severity (CGI-S) Scale Score During IND Phase
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Assessment method [5]
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CGI-S measures severity of participant's illness that include knowledge of participant's history, psychosocial circumstances, symptoms, behavior, impact of symptoms on participant's ability to function. CGI-S evaluates severity of psychopathology on a scale range from 0 - 7, where 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as "Endpoint".
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Timepoint [5]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
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Secondary outcome [6]
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Change From Baseline to Endpoint in CGI-S Scale Score During OP/MA Phase
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Assessment method [6]
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The CGI-S measures the severity of the participant's illness that include knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7, where 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the "Endpoint".
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Timepoint [6]
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Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
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Secondary outcome [7]
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Change From Baseline to Endpoint in Generalized Anxiety Disorder (GAD-7) Total Score During IND Phase
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Assessment method [7]
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GAD-7 is brief, validated 7-item self-reported assessment of overall anxiety. Participant's responded to each item using a 4 point scale with response categories: 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield total score ranges from 0 to 21, higher scores indicate more anxiety. Negative change in score indicates improvement. Severity of GAD-7 is categorized as: None (0-4), Mild (5-9), Moderate (10-14), Severe (15 -21). Missing data was imputed using LOCF method, last post baseline observation during the phase was carried forward as "Endpoint".
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Timepoint [7]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
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Secondary outcome [8]
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Change From Baseline to Endpoint in GAD-7 Total Score During OP/MA Phase
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Assessment method [8]
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GAD-7 is brief and validated 7-item self-reported assessment of overall anxiety. Participants respond to each item using a 4 point scale with response categories: 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score ranges from 0 to 21, higher scores indicate more anxiety. Negative change in score indicates improvement. Severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14), Severe (15 -21). Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the "Endpoint".
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Timepoint [8]
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Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
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Secondary outcome [9]
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Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During IND Phase: Sum Score
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Assessment method [9]
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EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state.
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Timepoint [9]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
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Secondary outcome [10]
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Change From Baseline to Endpoint in EQ-5D-5L Score During IND Phase: EQ-VAS
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Assessment method [10]
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EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine).
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Timepoint [10]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
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Secondary outcome [11]
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Change From Baseline to Endpoint in EQ-5D-5L Scale Score During IND Phase: Health Status Index
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Assessment method [11]
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EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a HSI. HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health).
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Timepoint [11]
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Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
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Secondary outcome [12]
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Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During OP/MA Phase: Sum Score
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Assessment method [12]
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EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state.
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Timepoint [12]
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0
Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
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Secondary outcome [13]
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Change From Baseline to Endpoint in EQ-5D-5L Score During OP/MA Phase: EQ-VAS
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Assessment method [13]
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EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine).
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Timepoint [13]
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0
Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
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Secondary outcome [14]
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Change From Baseline to Endpoint in EQ-5D-5L Scale Score During OP/MA Phase: Health Status Index
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Assessment method [14]
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EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a HSI. HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health).
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Timepoint [14]
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0
Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
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Secondary outcome [15]
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score During IND Phase
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Assessment method [15]
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SDS was a 5 item questionnaire used for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, (3) family life/home responsibilities using a 0 to 10 rating scale. Score for the first three items are summed to create a total score of 0 to 30, higher score indicates greater impairment and a negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the "Endpoint".
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Timepoint [15]
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0
Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND Phase)
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Secondary outcome [16]
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Change From Baseline in Sheehan Disability Scale Total Score During OP/MA Phase
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Assessment method [16]
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SDS was a participant-reported outcome measure and was a 5 item questionnaire used for assessment of functional impairment 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 to 10 rating scale. The score for the first three items are summed to create a total score of 0 to 30 where a higher score indicates greater impairment and a negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the "Endpoint".
Query!
Timepoint [16]
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0
Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)
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Secondary outcome [17]
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Percentage of Participants With Response as Assessed by MADRS Total Score During IND Phase
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Assessment method [17]
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Response is defined as greater than or equal to (>=) 50 % reduction from baseline in the MADRS total score. MADRS measures depression severity, detects changes due to AD treatment. It consists 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe condition. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the "Endpoint".
Query!
Timepoint [17]
0
0
Days 8, 15, 22 and Endpoint (last post-baseline assessment during 4 weeks of IND phase)
Query!
Secondary outcome [18]
0
0
Percentage of Participants With Response as Assessed by PHQ-9 Total Score During IND Phase
Query!
Assessment method [18]
0
0
Response is defined as >= 50 % reduction from baseline (IND phase) in PHQ-9 total score. PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. The scores are summed for a total score ranging from 0-27. A higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the "Endpoint".
Query!
Timepoint [18]
0
0
Day 15 and Endpoint (last post-baseline assessment value during 4 Week IND phase)
Query!
Secondary outcome [19]
0
0
Percentage of Participants With Remission as Assessed by MADRS Total Score During IND Phase
Query!
Assessment method [19]
0
0
Remission is defined as MADRS total score less than or equal to (<=) 12. MADRS measures depression severity, detects changes due to AD treatment. It consists 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe condition. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the "Endpoint".
Query!
Timepoint [19]
0
0
Days 8, 15, 22 and Endpoint (last post-baseline assessment value during 4 weeks of IND Phase)
Query!
Secondary outcome [20]
0
0
Percentage of Participants With Remission as Assessed by PHQ-9 Total Score During IND Phase
Query!
Assessment method [20]
0
0
Remission is defined as PHQ-9 total score <= 4. PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. The scores are summed for a total score ranging from 0-27. A higher score indicates greater severity of depression. severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the "Endpoint".
Query!
Timepoint [20]
0
0
Day 15 and Endpoint (last post-baseline assessment value during 4 weeks of IND phase)
Query!
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
Query!
Assessment method [21]
0
0
The CADSS used to measure present-state dissociative symptoms, and to assess treatment-emergent dissociative symptoms. It comprises 23 subjective items divided into 3 components: depersonalization (with score range from 0 to 28), derealization (with score range from 0 to 52), and amnesia (with score range from 0 to 8). Participants responses are coded on a 5-point scale (0 = "Not at all", 1 = "Mild", 2 = "Moderate", 3 = 'Severe" and 4 = "Extreme"). The total score is sum of the 23 items and range from 0 to 92, where 0 (best) and 92 (worst). A higher score indicates a more severe condition.
Query!
Timepoint [21]
0
0
Predose, up to 1.5 hours postdose (up to end of IND phase [Week 4])
Query!
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
Query!
Assessment method [22]
0
0
The CADSS used to measure present-state dissociative symptoms, and to assess treatment-emergent dissociative symptoms. It comprises 23 subjective items divided into 3 components: depersonalization (with score range from 0 to 28), derealization (with score range from 0 to 52), and amnesia (with score range from 0 to 8). Participants responses are coded on a 5-point scale (0 = "Not at all", 1 = "Mild", 2 = "Moderate", 3 = 'Severe" and 4 = "Extreme"). The total score is sum of the 23 items and range from 0 to 92, where 0 (best) and 92 (worst). A higher score indicates a more severe condition.
Query!
Timepoint [22]
0
0
Predose, up to 1.5 hours postdose (up to end of OP/MA phase [Week 52])
Query!
Secondary outcome [23]
0
0
Percentage of Participants With Treatment-Emergent Acute Hypertension (Systolic and Diastolic) During IND and OP/MA Phases
Query!
Assessment method [23]
0
0
Percentage of participants with treatment-emergent acute hypertension (Systolic Blood Pressure >=180 millimeters of mercury [mm Hg] or Diastolic Blood Pressure >= 110 mm Hg) during IND and OP/MA Phases were evaluated.
Query!
Timepoint [23]
0
0
Up to End of OP/MA phase (Week 52)
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/09/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
28/10/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
802
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Adelaide
Query!
Recruitment hospital [2]
0
0
- Caulfield
Query!
Recruitment hospital [3]
0
0
- Frankston
Query!
Recruitment hospital [4]
0
0
- Melbourne
Query!
Recruitment postcode(s) [1]
0
0
- Adelaide
Query!
Recruitment postcode(s) [2]
0
0
- Caulfield
Query!
Recruitment postcode(s) [3]
0
0
- Frankston
Query!
Recruitment postcode(s) [4]
0
0
- Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Connecticut
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Iowa
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kansas
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Maryland
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Massachusetts
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Ohio
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Pennsylvania
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
South Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Washington
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Banfield
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Buenos Aires
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Ciudad Autonoma de Buenos Aires
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Cordoba
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
La Plata
Query!
Country [19]
0
0
Argentina
Query!
State/province [19]
0
0
Mendoza
Query!
Country [20]
0
0
Argentina
Query!
State/province [20]
0
0
Rosario
Query!
Country [21]
0
0
Austria
Query!
State/province [21]
0
0
Innsbruck
Query!
Country [22]
0
0
Austria
Query!
State/province [22]
0
0
Vienna
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Brugge
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Hasselt
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Belo Horizonte
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Fortaleza
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Recife
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Rio de Janeiro
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Santo André
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
São José do Rio Preto
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
São Paulo
Query!
Country [32]
0
0
Bulgaria
Query!
State/province [32]
0
0
Bourgas
Query!
Country [33]
0
0
Bulgaria
Query!
State/province [33]
0
0
Kardzhali
Query!
Country [34]
0
0
Bulgaria
Query!
State/province [34]
0
0
Kazanlak
Query!
Country [35]
0
0
Bulgaria
Query!
State/province [35]
0
0
Pazardzhik
Query!
Country [36]
0
0
Bulgaria
Query!
State/province [36]
0
0
Pleven
Query!
Country [37]
0
0
Bulgaria
Query!
State/province [37]
0
0
Plovdiv
Query!
Country [38]
0
0
Bulgaria
Query!
State/province [38]
0
0
Rousse
Query!
Country [39]
0
0
Bulgaria
Query!
State/province [39]
0
0
Sofia
Query!
Country [40]
0
0
Bulgaria
Query!
State/province [40]
0
0
Varna
Query!
Country [41]
0
0
Finland
Query!
State/province [41]
0
0
Helsinki
Query!
Country [42]
0
0
Finland
Query!
State/province [42]
0
0
Kuopio
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Paris
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Poitiers
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Toulon
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
TOURS cedex 9
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Berlin
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Bochum
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Oranienburg-Sachsenhausen
Query!
Country [50]
0
0
Korea, Republic of
Query!
State/province [50]
0
0
Ansan-si
Query!
Country [51]
0
0
Korea, Republic of
Query!
State/province [51]
0
0
Gwangju
Query!
Country [52]
0
0
Korea, Republic of
Query!
State/province [52]
0
0
Seoul
Query!
Country [53]
0
0
Lithuania
Query!
State/province [53]
0
0
Kaunas
Query!
Country [54]
0
0
Lithuania
Query!
State/province [54]
0
0
Silute
Query!
Country [55]
0
0
Lithuania
Query!
State/province [55]
0
0
Vilnius
Query!
Country [56]
0
0
Malaysia
Query!
State/province [56]
0
0
Ipoh
Query!
Country [57]
0
0
Malaysia
Query!
State/province [57]
0
0
Johor Bahru
Query!
Country [58]
0
0
Malaysia
Query!
State/province [58]
0
0
Kuala Lumpur
Query!
Country [59]
0
0
Mexico
Query!
State/province [59]
0
0
Acapulco
Query!
Country [60]
0
0
Mexico
Query!
State/province [60]
0
0
Durango
Query!
Country [61]
0
0
Mexico
Query!
State/province [61]
0
0
Mexico City
Query!
Country [62]
0
0
Mexico
Query!
State/province [62]
0
0
Mexico
Query!
Country [63]
0
0
Mexico
Query!
State/province [63]
0
0
Monterrey
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Gdansk
Query!
Country [65]
0
0
South Africa
Query!
State/province [65]
0
0
Cape Town
Query!
Country [66]
0
0
South Africa
Query!
State/province [66]
0
0
Garsfontein
Query!
Country [67]
0
0
South Africa
Query!
State/province [67]
0
0
Pretoria
Query!
Country [68]
0
0
Spain
Query!
State/province [68]
0
0
Badajoz
Query!
Country [69]
0
0
Spain
Query!
State/province [69]
0
0
Bilbao
Query!
Country [70]
0
0
Spain
Query!
State/province [70]
0
0
Madrid
Query!
Country [71]
0
0
Spain
Query!
State/province [71]
0
0
Ourense
Query!
Country [72]
0
0
Spain
Query!
State/province [72]
0
0
Oviedo
Query!
Country [73]
0
0
Spain
Query!
State/province [73]
0
0
Sant Boi de Llobregat
Query!
Country [74]
0
0
Spain
Query!
State/province [74]
0
0
Torrevieja
Query!
Country [75]
0
0
Spain
Query!
State/province [75]
0
0
Valencia
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
Zamora
Query!
Country [77]
0
0
Sweden
Query!
State/province [77]
0
0
Goteborg
Query!
Country [78]
0
0
Sweden
Query!
State/province [78]
0
0
Halmstad
Query!
Country [79]
0
0
Sweden
Query!
State/province [79]
0
0
Lund
Query!
Country [80]
0
0
Sweden
Query!
State/province [80]
0
0
Skovde
Query!
Country [81]
0
0
Sweden
Query!
State/province [81]
0
0
Solna
Query!
Country [82]
0
0
Sweden
Query!
State/province [82]
0
0
Stockholm
Query!
Country [83]
0
0
Sweden
Query!
State/province [83]
0
0
Umea
Query!
Country [84]
0
0
Taiwan
Query!
State/province [84]
0
0
Kaohsiung
Query!
Country [85]
0
0
Taiwan
Query!
State/province [85]
0
0
New Taipei City
Query!
Country [86]
0
0
Taiwan
Query!
State/province [86]
0
0
Taichung
Query!
Country [87]
0
0
Taiwan
Query!
State/province [87]
0
0
Tainan
Query!
Country [88]
0
0
Taiwan
Query!
State/province [88]
0
0
Taipei
Query!
Country [89]
0
0
Taiwan
Query!
State/province [89]
0
0
Taoyuan County
Query!
Country [90]
0
0
Turkey
Query!
State/province [90]
0
0
Ankara
Query!
Country [91]
0
0
Turkey
Query!
State/province [91]
0
0
Bursa
Query!
Country [92]
0
0
Turkey
Query!
State/province [92]
0
0
Gaziantep
Query!
Country [93]
0
0
Turkey
Query!
State/province [93]
0
0
Istanbul
Query!
Country [94]
0
0
Turkey
Query!
State/province [94]
0
0
Kocaeli
Query!
Country [95]
0
0
Turkey
Query!
State/province [95]
0
0
Manisa
Query!
Country [96]
0
0
United Kingdom
Query!
State/province [96]
0
0
Bristol
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
Chesterfield
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
Derby
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
London
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
Middlesbrough
Query!
Country [101]
0
0
United Kingdom
Query!
State/province [101]
0
0
Northampton
Query!
Country [102]
0
0
United Kingdom
Query!
State/province [102]
0
0
Oxford
Query!
Country [103]
0
0
United Kingdom
Query!
State/province [103]
0
0
Preston
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Janssen Research & Development, LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02497287
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02497287
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