Comparison · NCT04338321-2c3ffa17
Esketamine Nasal Spray + Oral Antidepressant (AD) vs Quetiapine Extended Release (XR) + Oral AD: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Esketamine Nasal Spray + Oral Antidepressant (AD) vs Quetiapine Extended Release (XR) + Oral AD: Number of Participants With Treatment-emergent Adverse Events (TEAEs). Trial comparisons, record NCT04338321-2c3ffa17. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04338321-2c3ffa17
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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 | 0.919 | 0.885 | 0.944 | wilson | |
| Risk in group 2 | 0.78 | 0.732 | 0.821 | wilson | |
| Risk difference, group 1 minus group 2 | 0.139 | 0.086 | 0.193 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.18 | 1.1 | 1.26 | log | |
| Odds ratio, group 1 over group 2 | 3.21 | 2.01 | 5.14 | log | |
| Number needed to treat, for one more participant with the outcome on Esketamine Nasal Spray + Oral Antidepressant (AD) than on Quetiapine Extended Release (XR) + Oral AD | 7.17 | 5.19 | 11.6 | from the risk difference interval |
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). | 307 | 334 | OG000 |
| 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. | 262 | 336 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- Description
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs were those events if they started after administration of the first dose until 14 days after the last dose of study medication for other TEAEs except serious; and first dose until 30 days after the last dose of study medication for serious TEAEs.
- Time frame
- Up to Week 35
- Population
- The safety analysis set included all randomized participants who received at least 1 dose of any study intervention.
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.
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