Comparison · NCT04338321-sae
Esketamine Nasal Spray + Oral Antidepressant (AD) vs Quetiapine Extended Release (XR) + Oral AD: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Esketamine Nasal Spray + Oral Antidepressant (AD) vs Quetiapine Extended Release (XR) + Oral AD: serious adverse events. Trial comparisons, record NCT04338321-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04338321-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0569 | 0.0367 | 0.0871 | wilson | |
| Risk in group 2 | 0.0506 | 0.0318 | 0.0795 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00629 | -0.029 | 0.0419 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.12 | 0.595 | 2.12 | log | |
| Odds ratio, group 1 over group 2 | 1.13 | 0.578 | 2.22 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Esketamine Nasal Spray + Oral Antidepressant (AD) than on Quetiapine Extended Release (XR) + Oral AD | 159 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Esketamine Nasal Spray + Oral Antidepressant (AD) | Participants received treatment with esketamine nasal spray (28 milligrams \[mg\] \[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\], 56 mg \[initial dose for adult participants aged 18 to 64 years\], or 84 mg \[maximum dose esketamine nasal spray\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI). | 19 | 334 | EG000 |
| Group 2 | Quetiapine Extended Release (XR) + Oral AD | Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22. | 17 | 336 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All-cause mortality and serious adverse events: until 30 days after last dose (up to Week 35); other AEs: until 14 days after last dose (up to Week 33)
Source ClinicalTrials.gov
Trial
- Title
A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder
- NCT number
- NCT04338321
- Phases
- PHASE3
- Conditions
- Depressive Disorder, Major
- Interventions
- Esketamine 28 mg, Esketamine 56 mg, Esketamine 84 mg, Quetiapine XR 50 mg, Quetiapine XR 100 mg, Quetiapine XR 150 mg, SSRI/SNRI
- Lead sponsor
- Janssen-Cilag International NV
- Results first posted
- 2023-02-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04338321?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT04338321-sae