Comparison · NCT01427608-fa2f2231
Sertraline + Olanzapine vs Sertraline + Placebo: Number of Subjects at Risk of Relapse During the Randomized Phase.
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. Sertraline + Olanzapine vs Sertraline + Placebo: Number of Subjects at Risk of Relapse During the Randomized Phase. Trial comparisons, record NCT01427608-fa2f2231. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01427608-fa2f2231
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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 | 0.203 | 0.123 | 0.317 | wilson | |
| Risk in group 2 | 0.548 | 0.425 | 0.666 | wilson | |
| Risk difference, group 1 minus group 2 | -0.345 | -0.488 | -0.178 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.37 | 0.217 | 0.633 | log | |
| Odds ratio, group 1 over group 2 | 0.21 | 0.0955 | 0.462 | log | |
| Number needed to treat, for one fewer participant with the outcome on Sertraline + Olanzapine than on Sertraline + Placebo | 2.9 | 2.05 | 5.63 | 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 | Sertraline + Olanzapine | Randomized to continue with sertraline and olanzapine under double-blind conditions | 13 | 64 | OG000 |
| Group 2 | Sertraline + Placebo | Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions | 34 | 62 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Subjects at Risk of Relapse During the Randomized Phase.
- Description
Relapse criteria include at least one of the following:~1)Structured Clinical Interview for Diagnostic Statistical Manual #4 Trade Revision (DSM-IV-TR) Axis 1 Disorders (SCID) symptoms of major depression maintained over two weeks 2)17-item Hamilton Depression Rating Scale score of \>17 maintained for more than one week + a mean increase of 5 points from entry into randomized phase 3)Re-emergence of psychosis for more than one week, with a SADS (Schedule for Affective Disorders and Schizophrenia) score of \>2 on delusion or hallucination severity items 4)Significant clinical worsening defined as either emergence of high-risk of suicide, and/or development of mania for greater than one week, and/or psychiatric hospitalization.
- Time frame
- From entry into randomized phase (baseline) and 36 weeks or earlier relapse
- Population
Source ClinicalTrials.gov
Trial
- Title
- Sustaining Remission of Psychotic Depression
- NCT number
- NCT01427608
- Phases
- PHASE4
- Conditions
- Psychotic Depression
- Interventions
- Sertraline + Olanzapine, Sertraline + Placebo
- Lead sponsor
- Weill Medical College of Cornell University
- Results first posted
- 2019-03-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01427608?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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