Comparison · NCT01436149-sae
Antidepressant + Placebo vs Antidepressant + SPD489: 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. Antidepressant + Placebo vs Antidepressant + SPD489: serious adverse events. Trial comparisons, record NCT01436149-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01436149-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 | 0.0249 | 0.0107 | 0.0569 | wilson | |
| Risk in group 2 | 0.0149 | 0.00509 | 0.043 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00995 | -0.0215 | 0.0435 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.67 | 0.404 | 6.88 | log | |
| Odds ratio, group 1 over group 2 | 1.68 | 0.397 | 7.14 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Antidepressant + Placebo than on Antidepressant + SPD489 | 100 | 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 | Antidepressant + Placebo | Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489). | 5 | 201 | EG000 |
| Group 2 | Antidepressant + SPD489 | Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50 or 70 mg dose). | 3 | 201 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
- NCT number
- NCT01436149
- Phases
- PHASE3
- Conditions
- Major Depressive Disorder
- Interventions
- SPD489 (Lisdexamfetamine dimesylate ), Placebo
- Lead sponsor
- Shire
- Results first posted
- 2014-11-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01436149?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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