Comparison · NCT00667745-sae
OPT With Lithium vs OPT Without Lithium: serious adverse events
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. OPT With Lithium vs OPT Without Lithium: serious adverse events. Trial comparisons, record NCT00667745-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00667745-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 | 0.0993 | 0.0601 | 0.16 | wilson | |
| Risk in group 2 | 0.0845 | 0.049 | 0.142 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0148 | -0.0547 | 0.0849 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.563 | 2.45 | log | |
| Odds ratio, group 1 over group 2 | 1.19 | 0.532 | 2.68 | log | |
| Number needed to harm, for one more participant with a serious adverse event on OPT With Lithium than on OPT Without Lithium | 67.6 | 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 | OPT With Lithium | Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines. | 14 | 141 | EG000 |
| Group 2 | OPT Without Lithium | Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines. | 12 | 142 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder
- NCT number
- NCT00667745
- Phases
- PHASE4
- Conditions
- Bipolar Disorder
- Interventions
- Lithium Carbonate, Optimized Treatment (OPT)
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Results first posted
- 2013-06-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00667745?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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