A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression

NCT02497287 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: CR107148ESKETINTRD30042014-004587-38
• Study Type: interventional
• Target: 802
• Locations: 20 countries
• Sites: 105

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).

Conditions

Treatment-resistant Depression

Keywords

Treatment-resistant Depression; Esketamine; Oral Antidepressant

Outcome Measures

Primary Outcomes (11)

• Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

  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.

  Up to End of Follow up Phase (Week 56)

• Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders

  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).

  Up to End of Follow up Phase (Week 56)

• Change From Baseline in Cognitive Test Battery: Detection Test (DET) Score

  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.

  Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of Optimization/Maintenance [OP/MA] Phase)

• Change From Baseline in Cognitive Test Battery: Identification Test (IDN) Score

  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.

  Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

• Change From Baseline in Cognitive Test Battery: One Card Learning Test (OCL) Score

  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.

  Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

• Change From Baseline in Cognitive Test Battery: One Back Test (ONB) Score

  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.

  Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

• Change From Baseline in Cognitive Test Battery: Groton Maze Learning Test (GMLT) Score

  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.

  Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

• Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Total Recall

  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.

  Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

• Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Delayed Recall

  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.

  Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

• Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Number of Words Recalled

  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.

  Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

• Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Recognition Discrimination Index

  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.

  Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

Secondary Outcomes (23)

• Change From Baseline to Endpoint in Montgomery Asberg Depression Rating Scale (MADRS) Total Score During Induction (IND) Phase

  Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

• Change From Baseline to Endpoint in MADRS Total Score During Optimization/Maintenance (OP/MA) Phase

  Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

• Change From Baseline to Endpoint in Patient Health Questionnaire - 9 (PHQ-9) Total Score During IND Phase

  Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

• Change From Baseline to Endpoint in PHQ-9 Total Score During OP/MA Phase

  Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

• Change From Baseline to Endpoint in Clinical Global Impression of Severity (CGI-S) Scale Score During IND Phase

  Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

Study Arms (1)

Intranasal Esketamine plus oral antidepressant

EXPERIMENTAL

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.

Drug: Esketamine (Intranasal Spray); Drug: Duloxetine (Oral Antidepressant); Drug: Escitalopram (Oral Antidepressant); Drug: Sertraline (Oral Antidepressant); Drug: Venlafaxine Extended Release (XR) (Oral Antidepressant)

Interventions

Esketamine (Intranasal Spray) DRUG

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.

Intranasal Esketamine plus oral antidepressant

Duloxetine (Oral Antidepressant) DRUG

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).

Intranasal Esketamine plus oral antidepressant

Escitalopram (Oral Antidepressant) DRUG

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.

Intranasal Esketamine plus oral antidepressant

Sertraline (Oral Antidepressant) DRUG

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.

Intranasal Esketamine plus oral antidepressant

Venlafaxine Extended Release (XR) (Oral Antidepressant) DRUG

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.

Intranasal Esketamine plus oral antidepressant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (109)

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New Haven, Connecticut, United States

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Miami, Florida, United States

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Marietta, Georgia, United States

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Iowa City, Iowa, United States

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Wichita, Kansas, United States

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Baltimore, Maryland, United States

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Watertown, Massachusetts, United States

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Cedarhurst, New York, United States

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New York, New York, United States

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Staten Island, New York, United States

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Cincinnati, Ohio, United States

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Allentown, Pennsylvania, United States

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Charleston, South Carolina, United States

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Dallas, Texas, United States

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Wichita Falls, Texas, United States

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Richland, Washington, United States

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Banfield, Argentina

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Buenos Aires, Argentina

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Córdoba, Argentina

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La Plata, Argentina

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Mendoza, Argentina

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Rosario, Argentina

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Adelaide, Australia

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Caulfield, Australia

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Frankston, Australia

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Melbourne, Australia

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Innsbruck, Austria

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Vienna, Austria

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Bruges, Belgium

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Hasselt, Belgium

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Belo Horizonte, Brazil

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Fortaleza, Brazil

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Recife, Brazil

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Rio de Janeiro, Brazil

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Santo André, Brazil

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São José do Rio Preto, Brazil

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São Paulo, Brazil

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Burgas, Bulgaria

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Kardzhali, Bulgaria

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Kazanlak, Bulgaria

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Pazardzhik, Bulgaria

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Rousse, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Helsinki, Finland

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Kuopio, Finland

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Paris, France

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Poitiers, France

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Toulon, France

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Tours, France

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Berlin, Germany

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Bochum, Germany

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Oranienburg-Sachsenhausen, Germany

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Kaunas, Lithuania

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Šilutė, Lithuania

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Vilnius, Lithuania

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Ipoh, Malaysia

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Johor Bahru, Malaysia

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Kuala Lumpur, Malaysia

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Acapulco, Mexico

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Durango, Mexico

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Mexico City, Mexico

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México, Mexico

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Monterrey, Mexico

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Gdansk, Poland

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Cape Town, South Africa

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Garsfontein, South Africa

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Pretoria, South Africa

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Gwangju, South Korea

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Gyeonggi-do, South Korea

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Seoul, South Korea

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Badajoz, Spain

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Bilbao, Spain

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Madrid, Spain

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Ourense, Spain

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Oviedo, Spain

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Sant Boi de Llobregat, Spain

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Torrevieja, Spain

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Valencia, Spain

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Zamora, Spain

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Gothenburg, Sweden

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Halmstad, Sweden

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Lund, Sweden

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Skövde, Sweden

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Solna, Sweden

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Stockholm, Sweden

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Umeå, Sweden

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Kaohsiung City, Taiwan

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New Taipei City, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Ankara, Turkey (Türkiye)

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Bursa, Turkey (Türkiye)

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Gaziantep, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Kocaeli, Turkey (Türkiye)

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Manisa, Turkey (Türkiye)

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Bristol, United Kingdom

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Chesterfield, United Kingdom

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Derby, United Kingdom

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London, United Kingdom

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Middlesbrough, United Kingdom

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Northampton, United Kingdom

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Oxford, United Kingdom

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Preston, United Kingdom

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Related Publications (8)

• Oliveira-Maia AJ, Rive B, Godinov Y, Mulhern-Haughey S. Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remission: results from the ICEBERG study. Front Psychiatry. 2024 Oct 7;15:1459633. doi: 10.3389/fpsyt.2024.1459633. eCollection 2024.

  PMID: 39435126 DERIVED

• Oliveira-Maia AJ, Morrens J, Rive B, Godinov Y, Cabrieto J, Perualila N, Barbreau S, Mulhern-Haughey S. ICEBERG study: an indirect adjusted comparison estimating the long-term benefit of esketamine nasal spray when compared with routine treatment of treatment resistant depression in general psychiatry. Front Psychiatry. 2023 Oct 31;14:1250980. doi: 10.3389/fpsyt.2023.1250980. eCollection 2023.

  PMID: 38025433 DERIVED

• Oliveira-Maia AJ, Rive B, Morrens J, Godinov Y, Cabrieto J, Perualila N, Mulhern-Haughey S. Indirect adjusted comparison of 6-month clinical outcomes between esketamine nasal spray and other real-world polypharmacy treatment strategies for treatment resistant depression: results from the ICEBERG study. Front Psychiatry. 2023 Oct 31;14:1250987. doi: 10.3389/fpsyt.2023.1250987. eCollection 2023.

  PMID: 38025416 DERIVED

• Williamson D, Turkoz I, Wajs E, Singh JB, Borentain S, Drevets WC. Adverse Events and Measurement of Dissociation After the First Dose of Esketamine in Patients With TRD. Int J Neuropsychopharmacol. 2023 Mar 22;26(3):198-206. doi: 10.1093/ijnp/pyac081.

  PMID: 36525338 DERIVED

• 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.

  PMID: 36149841 DERIVED

• 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.

  PMID: 34750057 DERIVED

• 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.

  PMID: 32316080 DERIVED

• 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.

  PMID: 32270176 DERIVED

Related Links

• An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Esketamine; Duloxetine Hydrochloride; Antidepressive Agents; Escitalopram; Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Propylamines; Amines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Protocol defined study will be completed when at least 300 participants reach 26 weeks and 100 reach 52 weeks of treatment with esketamine. Discontinuation due to "Study terminated by sponsor" reflects reaching these prespecified completion criteria.

Results Point of Contact

• Title: Senior Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: July 14, 2015
• Study Start: September 30, 2015
• Primary Completion: October 28, 2017
• Study Completion: October 28, 2017
• Last Updated: April 29, 2025
• Results First Posted: April 29, 2019

Record last verified: 2025-04

Locations

PL (1); ZA (3); AU (2); BE (2); AR (6); BU (9); MY (3); KR (3); SE (7); TW (6); DE (3); TU (6); BR (7); FI (2); ES (9); GB (8); US (16); ME (5); FR (4); LI (3)