Comparison · NCT00931723-7a120278
Lithium+Quetiapine XR vs Placebo+Quetiapine XR: The Number of Patients With Clinically Significant Response.
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. Lithium+Quetiapine XR vs Placebo+Quetiapine XR: The Number of Patients With Clinically Significant Response. Trial comparisons, record NCT00931723-7a120278. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00931723-7a120278
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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 | 0.792 | 0.725 | 0.846 | wilson | |
| Risk in group 2 | 0.682 | 0.61 | 0.746 | wilson | |
| Risk difference, group 1 minus group 2 | 0.11 | 0.0176 | 0.2 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 1.02 | 1.32 | log | |
| Odds ratio, group 1 over group 2 | 1.78 | 1.09 | 2.88 | log | |
| Number needed to treat, for one more participant with the outcome on Lithium+Quetiapine XR than on Placebo+Quetiapine XR | 9.08 | 5 | 56.9 | 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 | Lithium+Quetiapine XR | Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day | 137 | 173 | OG000 |
| Group 2 | Placebo+Quetiapine XR | Placebo+quetiapine XR 400 to 800 mg/day | 120 | 176 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- The Number of Patients With Clinically Significant Response.
- Description
The number of patients with clinically significant response (defined as ≥50% reduction from baseline to Day 43 in the YMRS total score) was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms.
- Time frame
- 43 days (from baseline to Day 43)
- Population
173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).
Source ClinicalTrials.gov
Trial
- Title
- Adult Bipolar Mania
- NCT number
- NCT00931723
- Phases
- PHASE4
- Conditions
- Acute Mania
- Interventions
- Quetiapine fumarate XR, Lithium, Placebo
- Lead sponsor
- AstraZeneca
- Results first posted
- 2012-04-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00931723?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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