A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
NCT02782104 · SUSTAIN-3 · Janssen Research & Development, LLC
What it is testing
Summary
Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.
What counts as success
Primary outcome measures
Change From Study Baseline in Computerized Cognitive Battery Domain Score: Detection Test (DET) Score
Measured over IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Change From Study Baseline in Computerized Cognitive Battery Domain Score: Identification Test (IDN) Score
Measured over IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Card Learning Test (OCL) Score
Measured over IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Back Test (ONB) Score
Measured over IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Change From Study Baseline in Computerized Cognitive Battery Domain Score: Groton Maze Learning Test (GMLT) Score
Measured over IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Change From Study Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score
Measured over IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Percentage of Participants Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Measured over IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured over IND Phase: up to 4 weeks; OP/MA Phase: up to 78 months
Change From Baseline in Heart Rate
Measured over IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Change From Baseline in Systolic and Diastolic Blood Pressure
Measured over IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Change From Baseline in Respiratory Rate
Measured over IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
Change From Baseline in Blood Oxygen Saturation
Measured over IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.
Who can take part
Eligibility, as published
Where
173 study sites
| Facility | City | Region | Country |
|---|---|---|---|
| — | Birmingham | Alabama | United States |
| — | Little Rock | Arkansas | United States |
| — | Garden Grove | California | United States |
| — | Glendale | California | United States |
| — | Oakland | California | United States |
| — | Orange | California | United States |
| — | San Diego | California | United States |
| — | San Rafael | California | United States |
| — | Hartford | Connecticut | United States |
| — | New Haven | Connecticut | United States |
| — | Gainesville | Florida | United States |
| — | Miami | Florida | United States |
| — | Orlando | Florida | United States |
| — | Atlanta | Georgia | United States |
| — | Chicago | Illinois | United States |
| — | Hoffman Estates | Illinois | United States |
| — | Joliet | Illinois | United States |
| — | Maywood | Illinois | United States |
| — | Skokie | Illinois | United States |
| — | Iowa City | Iowa | United States |
| — | Wichita | Kansas | United States |
| — | Lake Charles | Louisiana | United States |
| — | Shreveport | Louisiana | United States |
| — | Baltimore | Maryland | United States |
| — | Gaithersburg | Maryland | United States |
| — | Boston | Massachusetts | United States |
| — | New Bedford | Massachusetts | United States |
| — | Watertown | Massachusetts | United States |
| — | Worcester | Massachusetts | United States |
| — | Rochester Hills | Michigan | United States |
| — | O'Fallon | Missouri | United States |
| — | Saint Charles | Missouri | United States |
| — | Omaha | Nebraska | United States |
| — | Cedarhurst | New York | United States |
| — | New York | New York | United States |
| — | Staten Island | New York | United States |
| — | Hickory | North Carolina | United States |
| — | Cincinnati | Ohio | United States |
| — | Oklahoma City | Oklahoma | United States |
| — | Allentown | Pennsylvania | United States |
| — | Media | Pennsylvania | United States |
| — | Philadelphia | Pennsylvania | United States |
| — | Lincoln | Rhode Island | United States |
| — | Providence | Rhode Island | United States |
| — | Charleston | South Carolina | United States |
| — | Austin | Texas | United States |
| — | Dallas | Texas | United States |
| — | Houston | Texas | United States |
| — | Wichita Falls | Texas | United States |
| — | Charlottesville | Virginia | United States |
| — | Waukesha | Wisconsin | United States |
| — | Banfield | — | Argentina |
| — | Buenos Aires | — | Argentina |
| — | Córdoba | — | Argentina |
| — | La Plata | — | Argentina |
| — | Mendoza | — | Argentina |
| — | Rosario | — | Argentina |
| — | Caulfield | — | Australia |
| — | Elizabeth Vale | — | Australia |
| — | Frankston | — | Australia |
| — | Vienna | — | Austria |
| — | Aalst | — | Belgium |
| — | Bruges | — | Belgium |
| — | Brussels | — | Belgium |
| — | Heusden-Zolder | — | Belgium |
| — | Liège | — | Belgium |
| — | Yvoir | — | Belgium |
| — | Belo Horizonte | — | Brazil |
| — | Curitiba | — | Brazil |
| — | Fortaleza | — | Brazil |
| — | Passo Fundo | — | Brazil |
| — | Porto Alegre | — | Brazil |
| — | Recife | — | Brazil |
| — | Rio de Janeiro | — | Brazil |
| — | São Bernardo do Campo | — | Brazil |
| — | São Paulo | — | Brazil |
| — | Burgas | — | Bulgaria |
| — | Kardzhali | — | Bulgaria |
| — | Pazardzhik | — | Bulgaria |
| — | Pleven | — | Bulgaria |
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On the registry
Contact the trial directly
This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.
Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.
NCT02782104 on ClinicalTrials.gov →
Last updated in the registry 2025-04-29. Registry records change; this page reflects the data build of 2026-08-25.
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