Comparison · NCT03113968-sae
Electroconvulsive Therapy (ECT) vs Ketamine Infusion: 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. Electroconvulsive Therapy (ECT) vs Ketamine Infusion: serious adverse events. Trial comparisons, record NCT03113968-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03113968-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 | 0.0235 | 0.00919 | 0.0589 | wilson | |
| Risk in group 2 | 0.0256 | 0.011 | 0.0586 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00211 | -0.0381 | 0.0362 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.918 | 0.25 | 3.36 | log | |
| Odds ratio, group 1 over group 2 | 0.916 | 0.242 | 3.47 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Electroconvulsive Therapy (ECT) than on Ketamine Infusion | 474 | 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 | Electroconvulsive Therapy (ECT) | Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion.~electroconvulsive therapy (ECT): ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression. | 4 | 170 | EG000 |
| Group 2 | Ketamine Infusion | Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion.~Ketamine: Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression. | 5 | 195 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline)
Source ClinicalTrials.gov
Trial
- Title
- ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)
- NCT number
- NCT03113968
- Phases
- PHASE2, PHASE3
- Conditions
- Treatment Resistant Depression, Electroconvulsive Therapy, ECT, Ketamine, Psychiatric Disorder, Depression, Major Depressive Disorder, Major Depressive Episode, Unipolar Depression
- Interventions
- electroconvulsive therapy (ECT), Ketamine
- Lead sponsor
- Bo Hu
- Results first posted
- 2023-08-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03113968?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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