Trial · NCT02782104
A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
NCT02782104, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2024-02-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression. Trials, record NCT02782104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02782104
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
- NCT number
- NCT02782104
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,148 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Depressive Disorder, Treatment-Resistant
- Interventions
- Esketamine Nasal Spray
- First posted
- 2016-05-25
- Last updated
- 2025-04-29
- Other registries' IDs
- eudract:2015-003578-34
- Results first posted
- 2024-02-20
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Study Baseline in Computerized Cognitive Battery Domain Score: Detection Test (DET) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | 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 subjects (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Total score ranged from 2 to 3.3 log 10 milliseconds (msec). Lower score indicated better performance. Higher change from baseline indicated better performance. |
| Primary | Change From Study Baseline in Computerized Cognitive Battery Domain Score: Identification Test (IDN) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | 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 ranged from 2 to 3.3 log 10 msec. Lower score indicated better performance. Higher change from baseline indicated better performance. |
| Primary | Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Card Learning Test (OCL) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | 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 indicated better performance. Higher change from baseline indicated better performance. |
| Primary | Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Back Test (ONB) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | 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 ranged from 2 to 3.54 log10 msec. Lower score indicated better performance. Higher change from baseline indicated better performance. |
| Primary | Change From Study Baseline in Computerized Cognitive Battery Domain Score: Groton Maze Learning Test (GMLT) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | 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 ranged from 0 to 999 number of errors. Lower score indicated better performance. Higher change from baseline indicated better performance. |
| Primary | Change From Study Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | The HVLT-R 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 total number of true-positive errors (0-12); and the range of recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher total recall score indicated higher cognition. The range of the recognition discrimination index is -12 to 12. Higher score indicated better performance and higher change from baseline indicated better performance. |
| Primary | Percentage of Participants Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | C-SSRS: interview-based instrument to systematically assess suicidal ideation (SI) and behavior, to assess whether participant experienced any of following: completed suicide, suicide attempt (response of "yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior ("yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active SI with methods without intent to act or some intent to act, without or with specific plan and intent), any self-injurious behavior with no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). Here, percentage of participants with \>=1 positive behavior, participants with \>=1 positive ideations; no event were reported. |
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | IND Phase: up to 4 weeks; OP/MA Phase: up to 78 months | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE occurring at or after the initial administration of study intervention up to end of study was considered as treatment-emergent. |
| Primary | Change From Baseline in Heart Rate | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | Change from baseline (predose) in heart rate were reported. |
| Primary | Change From Baseline in Systolic and Diastolic Blood Pressure | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | Change from baseline in systolic and diastolic blood pressure were reported. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Study Baseline in Computerized Cognitive Battery Domain Score: Detection Test (DET) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | log10 msec | MEAN |
| PRIMARY | Change From Study Baseline in Computerized Cognitive Battery Domain Score: Identification Test (IDN) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | log10 msec | MEAN |
| PRIMARY | Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Card Learning Test (OCL) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Arcsine (sqrt of percentage of CR) | MEAN |
| PRIMARY | Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Back Test (ONB) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | log10 msec | MEAN |
| PRIMARY | Change From Study Baseline in Computerized Cognitive Battery Domain Score: Groton Maze Learning Test (GMLT) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Number of Errors | MEAN |
| PRIMARY | Change From Study Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | score on a scale | MEAN |
| PRIMARY | Percentage of Participants Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | IND Phase: up to 4 weeks; OP/MA Phase: up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Heart Rate | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | Full analysis set included participants who received at least 1 dose of intranasal study medication in this study. | beats per minute | MEAN |
| PRIMARY | Change From Baseline in Systolic and Diastolic Blood Pressure | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | Full analysis set included participants who received at least 1 dose of intranasal study medication in this study. | Millimeters of mercury (mmHg) | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Study Baseline in Computerized Cognitive Battery Domain Score: Detection Test (DET) Score | Esketamine Nasal Spray (IND Phase) | 0.0218 | Standard Deviation 0.10516 | log10 msec | |
| Change From Study Baseline in Computerized Cognitive Battery Domain Score: Detection Test (DET) Score | Esketamine Nasal Spray (OP/MA Phase) | -0.0065 | Standard Deviation 0.13526 | log10 msec | |
| Change From Study Baseline in Computerized Cognitive Battery Domain Score: Identification Test (IDN) Score | Esketamine Nasal Spray (IND Phase) | 0.0074 | Standard Deviation 0.07819 | log10 msec | |
| Change From Study Baseline in Computerized Cognitive Battery Domain Score: Identification Test (IDN) Score | Esketamine Nasal Spray (OP/MA Phase) | -0.0185 | Standard Deviation 0.09893 | log10 msec | |
| Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Card Learning Test (OCL) Score | Esketamine Nasal Spray (IND Phase) | 0.0170 | Standard Deviation 0.12356 | Arcsine (sqrt of percentage of CR) | |
| Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Card Learning Test (OCL) Score | Esketamine Nasal Spray (OP/MA Phase) | 0.0397 | Standard Deviation 0.15364 | Arcsine (sqrt of percentage of CR) | |
| Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Back Test (ONB) Score | Esketamine Nasal Spray (IND Phase) | 0.0086 | Standard Deviation 0.08096 | log10 msec | |
| Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Back Test (ONB) Score | Esketamine Nasal Spray (OP/MA Phase) | 0.0198 | Standard Deviation 0.10329 | log10 msec | |
| Change From Study Baseline in Computerized Cognitive Battery Domain Score: Groton Maze Learning Test (GMLT) Score | Esketamine Nasal Spray (IND Phase) | 1.5 | Standard Deviation 17.80 | Number of Errors | |
| Change From Study Baseline in Computerized Cognitive Battery Domain Score: Groton Maze Learning Test (GMLT) Score | Esketamine Nasal Spray (OP/MA Phase) | 5.1 | Standard Deviation 22.52 | Number of Errors |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Esketamine Nasal Spray | 1,148 | |
| Overall Study | IND Phase | Esketamine Nasal Spray | 458 | |
| Overall Study | OP/MA Phase | Esketamine Nasal Spray | 1,110 | |
| Overall Study | COMPLETED | Esketamine Nasal Spray | 680 | |
| Overall Study | NOT COMPLETED | Esketamine Nasal Spray | 468 |
Source ClinicalTrials.gov
Adverse events476
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Ear and labyrinth disorders | Esketamine Nasal Spray (IND Phase) | 77 | 458 | |
| other | Vertigo | Ear and labyrinth disorders | Esketamine Nasal Spray (OP/MA Phase) | 198 | 1,110 | |
| other | Diplopia | Eye disorders | Esketamine Nasal Spray (IND Phase) | 15 | 458 | |
| other | Diplopia | Eye disorders | Esketamine Nasal Spray (OP/MA Phase) | 58 | 1,110 | |
| other | Vision Blurred | Eye disorders | Esketamine Nasal Spray (IND Phase) | 35 | 458 | |
| other | Vision Blurred | Eye disorders | Esketamine Nasal Spray (OP/MA Phase) | 116 | 1,110 | |
| other | Abdominal Pain | Gastrointestinal disorders | Esketamine Nasal Spray (IND Phase) | 4 | 458 | |
| other | Abdominal Pain | Gastrointestinal disorders | Esketamine Nasal Spray (OP/MA Phase) | 70 | 1,110 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Esketamine Nasal Spray (IND Phase) | 6 | 458 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Esketamine Nasal Spray (OP/MA Phase) | 80 | 1,110 |
1 to 10 of 476Source ClinicalTrials.gov
See all 476 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Esketamine Nasal Spray (IND Phase) | 1 | 458 |
| Total, all-cause mortality | Esketamine Nasal Spray (OP/MA Phase) | 8 | 1,110 |
| Total, other adverse events | Esketamine Nasal Spray (IND Phase) | 318 | 458 |
| Total, other adverse events | Esketamine Nasal Spray (OP/MA Phase) | 1,010 | 1,110 |
| Total, serious adverse events | Esketamine Nasal Spray (IND Phase) | 5 | 458 |
| Total, serious adverse events | Esketamine Nasal Spray (OP/MA Phase) | 212 | 1,110 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Esketamine Nasal Spray (IND Phase) vs Esketamine Nasal Spray (OP/MA Phase): Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| Esketamine Nasal Spray (IND Phase) vs Esketamine Nasal Spray (OP/MA Phase): deaths from any cause | Trial comparisons |
| Esketamine Nasal Spray (IND Phase) vs Esketamine Nasal Spray (OP/MA Phase): serious adverse events | Trial comparisons |
Tests5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Primary outcome | ConductCognition |
| Choice Reaction Time | Primary outcome | ConductCognition |
| Hidden Path Learning | Primary outcome | ConductCognition |
| Simple Reaction Time | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT02782104
GET https://conductscience.org/api/trials/v1/NCT02782104/results?page=2