Trial · NCT02497287
A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression
NCT02497287, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2019-04-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression. Trials, record NCT02497287. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02497287
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression
- NCT number
- NCT02497287
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 802 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Treatment-resistant Depression
- Interventions
- Esketamine (Intranasal Spray), Duloxetine (Oral Antidepressant), Escitalopram (Oral Antidepressant), Sertraline (Oral Antidepressant), Venlafaxine Extended Release (XR) (Oral Antidepressant)
- First posted
- 2015-07-14
- Last updated
- 2025-04-29
- Other registries' IDs
- eudract:2014-004587-38
- Results first posted
- 2019-04-29
- 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.
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to End of Follow up Phase (Week 56) | 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. |
| Primary | Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders | 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 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). |
| Primary | Change From Baseline in Cognitive Test Battery: Detection Test (DET) Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of Optimization/Maintenance [OP/MA] Phase) | 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. |
| Primary | Change From Baseline in Cognitive Test Battery: Identification Test (IDN) Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | 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. |
| Primary | Change From Baseline in Cognitive Test Battery: One Card Learning Test (OCL) Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | 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. |
| Primary | Change From Baseline in Cognitive Test Battery: One Back Test (ONB) Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | 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. |
| Primary | Change From Baseline in Cognitive Test Battery: Groton Maze Learning Test (GMLT) Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | 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. |
| Primary | Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Total Recall | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | 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. |
| Primary | Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Delayed Recall | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | 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. |
| Primary | Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Number of Words Recalled | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | 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. |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to End of Follow up Phase (Week 56) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders | Up to End of Follow up Phase (Week 56) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. | Percentage of participants | NUMBER |
| PRIMARY | Change From Baseline in Cognitive Test Battery: Detection Test (DET) Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of Optimization/Maintenance [OP/MA] Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | log10 msec | MEAN |
| PRIMARY | Change From Baseline in Cognitive Test Battery: Identification Test (IDN) Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | log10 msec | MEAN |
| PRIMARY | Change From Baseline in Cognitive Test Battery: One Card Learning Test (OCL) Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Arcsine ([sqrt] of proportion of [CR]) | MEAN |
| PRIMARY | Change From Baseline in Cognitive Test Battery: One Back Test (ONB) Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | log10 msec | MEAN |
| PRIMARY | Change From Baseline in Cognitive Test Battery: Groton Maze Learning Test (GMLT) Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Number of Errors | MEAN |
| PRIMARY | Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Total Recall | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Number correct | MEAN |
| PRIMARY | Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Delayed Recall | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Number correct | MEAN |
| PRIMARY | Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Number of Words Recalled | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Number of words recalled | MEAN |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group47
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Intranasal Esketamine + Oral Antidepressant | 90.1 | Percentage of participants | ||
| Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders | Intranasal Esketamine + Oral Antidepressant | Cystitis | 0.6 | Percentage of participants | |
| Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders | Intranasal Esketamine + Oral Antidepressant | Urinary tract infections | 8.1 | Percentage of participants | |
| Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders | Intranasal Esketamine + Oral Antidepressant | Renal and urinary disorders | 10.5 | Percentage of participants | |
| Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders | Intranasal Esketamine + Oral Antidepressant | Renal and urinary tract symptoms | 17.0 | Percentage of participants | |
| Change From Baseline in Cognitive Test Battery: Detection Test (DET) Score | Intranasal Esketamine + Oral Antidepressant | -0.0028 | Standard Deviation 0.12744 | log10 msec | |
| Change From Baseline in Cognitive Test Battery: Identification Test (IDN) Score | Intranasal Esketamine + Oral Antidepressant | -0.0083 | Standard Deviation 0.09656 | log10 msec | |
| Change From Baseline in Cognitive Test Battery: One Card Learning Test (OCL) Score | Intranasal Esketamine + Oral Antidepressant | 0.0502 | Standard Deviation 0.13149 | Arcsine ([sqrt] of proportion of [CR]) | |
| Change From Baseline in Cognitive Test Battery: One Back Test (ONB) Score | Intranasal Esketamine + Oral Antidepressant | 0.0177 | Standard Deviation 0.10026 | log10 msec | |
| Change From Baseline in Cognitive Test Battery: Groton Maze Learning Test (GMLT) Score | Intranasal Esketamine + Oral Antidepressant | 6.9 | Standard Deviation 25.36 | Number of Errors |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Phase (4 Weeks) | STARTED | Intranasal Esketamine + Oral Antidepressant | 779 | |
| Induction Phase (4 Weeks) | COMPLETED | Intranasal Esketamine + Oral Antidepressant | 580 | |
| Induction Phase (4 Weeks) | NOT COMPLETED | Intranasal Esketamine + Oral Antidepressant | 199 | |
| Optimization/Maintenance (48 Weeks) | STARTED | Intranasal Esketamine + Oral Antidepressant | 603 | |
| Optimization/Maintenance (48 Weeks) | COMPLETED | Intranasal Esketamine + Oral Antidepressant | 150 | |
| Optimization/Maintenance (48 Weeks) | NOT COMPLETED | Intranasal Esketamine + Oral Antidepressant | 453 | |
| Follow-up Phase (4 Week) | STARTED | Intranasal Esketamine + Oral Antidepressant | 357 | |
| Follow-up Phase (4 Week) | COMPLETED | Intranasal Esketamine + Oral Antidepressant | 326 | |
| Follow-up Phase (4 Week) | NOT COMPLETED | Intranasal Esketamine + Oral Antidepressant | 31 |
Source ClinicalTrials.gov
Adverse events216
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 | IND: Intranasal Esketamine + Oral AD | 68 | 779 | |
| other | Vertigo | Ear and labyrinth disorders | OP/MA: Intranasal Esketamine + Oral AD | 43 | 603 | |
| other | Vertigo | Ear and labyrinth disorders | FU: Intranasal Esketamine + Oral AD | 1 | 357 | |
| other | Vision Blurred | Eye disorders | IND: Intranasal Esketamine + Oral AD | 49 | 779 | |
| other | Vision Blurred | Eye disorders | OP/MA: Intranasal Esketamine + Oral AD | 25 | 603 | |
| other | Vision Blurred | Eye disorders | FU: Intranasal Esketamine + Oral AD | 0 | 357 | |
| other | Diarrhoea | Gastrointestinal disorders | IND: Intranasal Esketamine + Oral AD | 27 | 779 | |
| other | Diarrhoea | Gastrointestinal disorders | OP/MA: Intranasal Esketamine + Oral AD | 39 | 603 | |
| other | Diarrhoea | Gastrointestinal disorders | FU: Intranasal Esketamine + Oral AD | 2 | 357 | |
| other | Hypoaesthesia Oral | Gastrointestinal disorders | IND: Intranasal Esketamine + Oral AD | 63 | 779 |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IND: Intranasal Esketamine + Oral AD | 0 | 779 |
| Total, all-cause mortality | OP/MA: Intranasal Esketamine + Oral AD | 2 | 603 |
| Total, all-cause mortality | FU: Intranasal Esketamine + Oral AD | 0 | 357 |
| Total, other adverse events | IND: Intranasal Esketamine + Oral AD | 587 | 779 |
| Total, other adverse events | OP/MA: Intranasal Esketamine + Oral AD | 454 | 603 |
| Total, other adverse events | FU: Intranasal Esketamine + Oral AD | 24 | 357 |
| Total, serious adverse events | IND: Intranasal Esketamine + Oral AD | 17 | 779 |
| Total, serious adverse events | OP/MA: Intranasal Esketamine + Oral AD | 38 | 603 |
| Total, serious adverse events | FU: Intranasal Esketamine + Oral AD | 8 | 357 |
Source ClinicalTrials.gov
Papers9
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02497287
GET https://conductscience.org/api/trials/v1/NCT02497287/registered?page=2