drugset / Trial / NCT02522377
Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketamine | Small molecule | — | Intravenous |
| Comparator | Midazolam | Small molecule | — | Intravenous |