Comparison · NCT02229825-sae
60 mg Duloxetine vs 120 mg Duloxetine: serious adverse events
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. 60 mg Duloxetine vs 120 mg Duloxetine: serious adverse events. Trial comparisons, record NCT02229825-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02229825-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 | 0.0359 | 0.0166 | 0.0762 | wilson | |
| Risk in group 2 | 0.0351 | 0.0162 | 0.0744 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00084 | -0.043 | 0.0453 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.337 | 3.11 | log | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.324 | 3.24 | log | |
| Number needed to harm, for one more participant with a serious adverse event on 60 mg Duloxetine than on 120 mg Duloxetine | 1,190 | 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 | 60 mg Duloxetine | 1 capsule of 60 milligram (mg) duloxetine was administered orally once daily in the morning and 1 capsule of placebo was administered orally once daily in the evening, each with a glass of water, with or without food for the first 4 weeks of treatment. At Visit 6 (week 4) patients were classified by the Montgomery-Asberg Depression Rating Scale (MADRS) as responders or non-responders. From week 4 to end of treatment responders (defined as ≥50% change in total MADRS score from baseline) continued with the same dosing regimen. Non-responders were up-titrated to 120 mg of duloxetine (1 capsule of 60 mg duloxetine in the morning and 1 capsule of 60 mg duloxetine + 1 placebo capsule in the evening). | 6 | 167 | EG000 |
| Group 2 | 120 mg Duloxetine | From day 1 to day 3, 1 capsule of 60 mg duloxetine was administered orally once daily in the morning and 1 capsule of placebo was administered orally once daily in the evening, each with a glass of water, with or without food. From day 4 until Visit 6, the dose was escalated to 120 mg (forced titration), with 1 capsule of duloxetine administered orally once daily in the morning and one in the evening. At Visit 6 (week 4) patients were classified by the Montgomery-Asberg Depression Rating Scale (MARDS) as responders or non-responders. From week 4 to end of treatment responders (defined as ≥50% change in total MADRS score from baseline) continued with the same dosing regimen. Non-responders were up-titrated to 3 capsules a day, remaining at 120 mg dose of duloxetine (1 capsule of 60 mg duloxetine in the morning and one in the evening and 1 placebo capsule in the evening). | 6 | 171 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first drug administration until last drug administration (average duration of 55.1 days), plus 3 days, up to 120 days.
Source ClinicalTrials.gov
Trial
- Title
- Study to Assess Clinical Response of Duloxetine in Patients Hospitalized for Severe Depression
- NCT number
- NCT02229825
- Phases
- PHASE4
- Conditions
- Depressive Disorder, Major
- Interventions
- Duloxetine, Placebo
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2023-10-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02229825?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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GET https://conductscience.org/api/comparisons/v1/NCT02229825-sae