Comparison · NCT02229825-976141cc
60 mg Duloxetine vs 120 mg Duloxetine: Number of Patients Withdrawn Due to Adverse Events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ConductScience Library. 60 mg Duloxetine vs 120 mg Duloxetine: Number of Patients Withdrawn Due to Adverse Events. Trial comparisons, record NCT02229825-976141cc. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02229825-976141cc
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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 | 0.0659 | 0.0372 | 0.114 | wilson | |
| Risk in group 2 | 0.0526 | 0.0279 | 0.097 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0132 | -0.0396 | 0.0674 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.25 | 0.532 | 2.94 | log | |
| Odds ratio, group 1 over group 2 | 1.27 | 0.512 | 3.15 | log | |
| Number needed to treat, for one more participant with the outcome on 60 mg Duloxetine than on 120 mg Duloxetine | 75.5 | 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). | 11 | 167 | OG000 |
| 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). | 9 | 171 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Patients Withdrawn Due to Adverse Events
- Description
- Number of patients withdrawn due to adverse events.~Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
- Time frame
- From start of treatment until 3 days after end of treatment, up to 120 days.
- Population
Treated Set (TRS): All randomised patients treated with at least one dose of duloxetine. Participants randomised but not treated with at least one dose of duloxetine were excluded, as they cannot contribute information on the drug effect. Treatment regimen.
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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