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Comparison · NCT01179009-sae

Ketamine 100-hour Infusion vs Ketamine 40-minute 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

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ConductScience Library. Ketamine 100-hour Infusion vs Ketamine 40-minute Infusion: serious adverse events. Trial comparisons, record NCT01179009-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01179009-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.278wilson
Risk in group 2000.278wilson
Risk difference, group 1 minus group 20-0.2780.278newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Ketamine 100-hour Infusion
100-hour infusion of ketamine plus a safener (clonidine)~Ketamine: Controlled IV ketamine infusion (0.00225mg/kg-min. \[18% (0.0125 mg/kg-min.).~Clonidine: Participants will receive an approximately 5-day pretreatment of clonidine (max. dose 1mg/day divided doses) prior to and throughout the ketamine infusion.~Scopolamine Transdermal Product: Some participants will receive a scopolamine transdermal patch prior to and throughout their infusion/injections visits.
010EG000
Group 2Ketamine 40-minute Infusion
40-minute ketamine infusion following a 100-hours +/- placebo (saline) infusion. Participants will also receive a safener (clonidine)~Ketamine: Controlled IV ketamine infusion (0.00225mg/kg-min. \[18% (0.0125 mg/kg-min.).~Clonidine: Participants will receive an approximately 5-day pretreatment of clonidine (max. dose 1mg/day divided doses) prior to and throughout the ketamine infusion.~placebo: IV saline (i.e. placebo ketamine)
010EG001

Harm

What it counts
Total, serious adverse events
Time frame
Symptoms were measured 4 times daily over the course of the 4-day infusion using the Brief Psychiatric Rating Scale and the Clinical and Adverse Events Checklist. For symptoms that occurred on more than one assessment, the highest severity rating is reported.

Source ClinicalTrials.gov

Trial

Title
Treatment Resistant Depression (Pilot)
NCT number
NCT01179009
Phases
NA
Conditions
Depressive Disorder, Treatment-Resistant
Interventions
Ketamine, Clonidine, placebo
Lead sponsor
Washington University School of Medicine
Results first posted
2023-09-15

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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