Comparison · NCT00931723-c5f2c8b5
Lithium+Quetiapine XR vs Placebo+Quetiapine XR: Improvement of Overall Bipolar Illness
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. Lithium+Quetiapine XR vs Placebo+Quetiapine XR: Improvement of Overall Bipolar Illness. Trial comparisons, record NCT00931723-c5f2c8b5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00931723-c5f2c8b5
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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 | 0.775 | 0.707 | 0.83 | wilson | |
| Risk in group 2 | 0.71 | 0.639 | 0.772 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0643 | -0.0275 | 0.155 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.09 | 0.963 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 1.4 | 0.865 | 2.27 | log | |
| Number needed to treat, for one more participant with the outcome on Lithium+Quetiapine XR than on Placebo+Quetiapine XR | 15.5 | 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 | Lithium+Quetiapine XR | Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day | 134 | 173 | OG000 |
| Group 2 | Placebo+Quetiapine XR | Placebo+quetiapine XR 400 to 800 mg/day | 125 | 176 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Improvement of Overall Bipolar Illness
- Description
The number of patients with a CGI-BP-C of Much or Very much improved in overall bipolar illness assessment at Day 43 was calculated.~The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). A missing score will be used when a scale scored as 8 (not applicable). CGI-BP-C scores \>4 indicate worsening, while scores \<4 indicate improvement.
- Time frame
- 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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