Comparison · NCT01001559-sae
Deplin + Antidepressant vs Antidepressant Alone: 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. Deplin + Antidepressant vs Antidepressant Alone: serious adverse events. Trial comparisons, record NCT01001559-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01001559-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 | 0.0108 | 0.0019 | 0.0584 | wilson | |
| Risk in group 2 | 0.0291 | 0.00995 | 0.0822 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0184 | -0.0721 | 0.033 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.369 | 0.0391 | 3.49 | log | |
| Odds ratio, group 1 over group 2 | 0.362 | 0.037 | 3.55 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Deplin + Antidepressant than on Antidepressant Alone | 54.4 | 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 | Deplin + Antidepressant | Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) | 1 | 93 | EG000 |
| Group 2 | Antidepressant Alone | SSRI or SNRI alone | 3 | 103 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AE reporting occurred between January 2007 and September 2009
Source ClinicalTrials.gov
Trial
- Title
- Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis
- NCT number
- NCT01001559
- Phases
- Conditions
- Major Depressive Disorder
- Interventions
- L-methylfolate, Selective serotonin reuptake inhibitor (SSRI), Serotonin and norepinephrine reuptake inhibitor (SNRI)
- Lead sponsor
- Pamlab, Inc.
- Results first posted
- 2013-12-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01001559?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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