Comparison · NCT01907217-sae
Bilateral ECT Mecta 5000M vs High-dose Unilateral ECT Mecta 5000M: 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. Bilateral ECT Mecta 5000M vs High-dose Unilateral ECT Mecta 5000M: serious adverse events. Trial comparisons, record NCT01907217-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01907217-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 | 0.13 | 0.0702 | 0.23 | wilson | |
| Risk in group 2 | 0.101 | 0.05 | 0.195 | wilson | |
| Risk difference, group 1 minus group 2 | 0.029 | -0.0822 | 0.141 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.29 | 0.507 | 3.26 | log | |
| Odds ratio, group 1 over group 2 | 1.33 | 0.465 | 3.79 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Bilateral ECT Mecta 5000M than on High-dose Unilateral ECT Mecta 5000M | 34.5 | 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 | Bilateral ECT Mecta 5000M | Twice-weekly modified bilateral ECT (bitemporal electrode positions) twice weekly at 1.5 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.~Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks. | 9 | 69 | EG000 |
| Group 2 | High-dose Unilateral ECT Mecta 5000M | Twice-weekly high-dose right modified unilateral ECT twice weekly at 6 times the seizure threshold. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0mg/kg) for muscle relaxation.~Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks. | 7 | 69 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Participants were monitored for ECT-related adverse events during individual ECT sessions and throughout the ECT treatment course, an average of four weeks per participant. They were also monitored for any other adverse events (not directly related to treatment with ECT) throughout the six month follow-up.
Source ClinicalTrials.gov
Trial
- Title
- Enhancing the Effectiveness of Electroconvulsive Therapy in Severe Depression
- NCT number
- NCT01907217
- Phases
- PHASE4
- Conditions
- Depression
- Interventions
- ECT Mecta 5000M, Methohexitone, Suxamethonium
- Lead sponsor
- St Patrick's Hospital, Ireland
- Results first posted
- 2018-11-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01907217?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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