Oral esketamine for treatment-resistant depression: rationale and design of a randomized controlled trial.
BMC psychiatry November 29, 2019 Sanne Y Smith-Apeldoorn, Jolien K E Veraart, Jeanine Kamphuis et al.
A triple-blind randomized placebo-controlled trial investigates daily oral esketamine versus placebo as an add-on to regular antidepressants in patients with treatment-resistant depression over 6 weeks, followed by a 4-week follow-up. This is the first such trial to examine the efficacy, safety, tolerability, mechanisms of action, and economic impact of repeated oral esketamine administration. If effective and tolerated, oral esketamine offers practical advantages over intravenous administration. The study aims to address the urgent need for additional treatment strategies for treatment-resistant depression.