Intramuscular Ketamine Versus Aripiprazole and Escitalopram in the Treatment of Resistant Depression (KETProject)
This study aims to compare the response of ketamine IM versus active control in treatment-resistant depression (TRD [primary outcome]) and find safety and tolerability of ketamine IM, evaluate changes in life quality, cognition and suicidal risk (secondary outcomes).
Details
Randomized, quadruple-blind, parallel-group Phase IV trial comparing intramuscular ketamine (0.75 mg/kg IM three times weekly for 4 weeks, then weekly maintenance for 6 months) with IM saline plus oral escitalopram 15 mg and aripiprazole 5 mg in participants with treatment-resistant depression.
Primary outcome is antidepressant response in TRD; secondary outcomes include safety/tolerability (UKU-SERS, CADSS, BPRS-12), cognition, quality of life, and suicidal risk; vital signs monitored continuously for 2 hours after each injection.