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Using a Low Dose of Ketamine vs. Active Placebo in Treating Severe Depression and Suicide

Unknown statusRegisteredCTG

Double-blind, randomised, parallel-group trial (n=48) comparing a single 0.5 mg/kg ketamine infusion versus active placebo midazolam 0.045 mg/kg in adults with treatment-resistant depression to assess antidepressant and antisuicidal effects.

Details

This double-blind, randomised, parallel-group study in Taiwan enrols 48 adults with treatment-resistant major depression to compare a single subanaesthetic ketamine infusion (0.5 mg/kg) with an active midazolam placebo (0.045 mg/kg).

Primary outcomes are antidepressant response by MADRS and HAMD ratings and changes in suicide-related symptoms; assessments are conducted from baseline through 14 days post-infusion. The trial builds on prior evidence of rapid antidepressant and antisuicidal effects of ketamine and seeks to validate these effects in a Han Chinese population.

Topics:Treatment-Resistant Depression (TRD)

Registry

Registry linkNCT03666390