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A Study of Ketamine in Patients With Treatment-resistant Depression

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Randomized, double-blind, placebo-controlled, parallel Phase II study (n=68) comparing IV ketamine 0.5 mg/kg given 2 or 3 times weekly for 4 weeks in patients with treatment-resistant major depressive disorder to determine optimal dosing frequency.

Details

Double-blind, randomized, parallel-group Phase II trial comparing intravenous ketamine 0.50 mg/kg administered two or three times per week versus matching placebo over a 4-week double-blind treatment phase (Day 1 to Day 29).

Each patient undergoes screening up to 4 weeks, a 4-week double-blind treatment period and a 3-week post-treatment follow-up; key outcomes include antidepressant response and safety/tolerability. Patients were inpatient or agreed to be admitted on dosing days.

Topics:Major Depressive Disorder (MDD)

Registry

Registry linkNCT01627782