drugset / Trial / NCT02522377

Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression

NCT02522377 ↗

Completed 15 enrolled The Cleveland Clinic
RandomizedParallel-groupQuadruple-blindTreatment

Summary

In this proof of concept study, the investigators plan to administer iv ketamine interleaved with ECT days. Patients with treatment resistant depression who are deemed to be eligible for ECT treatment will randomly be assigned to either ketamine or active placebo.

Timeline

Start
2015-08
Primary completion
2018-03-01
Completion
2018-03-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Ketamine Infusions vs Midazolam; p = 0.72; Mean Difference (Final Values) 1.22; Mixed Models Analysis NCT02522377 ↗

registry analysis (superiority test); Ketamine Infusions vs Midazolam; p = 0.77; Mean Difference (Final Values) 1.98; Mixed Models Analysis NCT02522377 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule — Intravenous
Comparator Midazolam Small molecule — Intravenous