In a recent study published in the journal Nature Medicine , an international team of researchers evaluated the efficacy , safety, and tolerability of extended-release ketamine tablets (R-107) in adult patients with treatment-resistant depression (TRD) through a randomized placebo-controlled phase 2 trial. Study: Extended-release ketamine tablets for treatment-resistant depression: a randomized placebo-controlled phase 2 trial . Image Credit: Djavan Rodriguez / Shutterstock Over the past two decades, substantial evidence has demonstrated the rapid-onset antidepressant properties of ketamine in patients with TRD.
Most research has involved off-label intravenous racemic ketamine, with the recent approval of intranasal esketamine for TRD. Only a few randomized controlled trials for TRD have explored oral dosing. Ketamine and esketamine, administered via various routes, show higher doses linked to greater depression improvement.
Oral ketamine’s prolonged exposure to metabolites, such as norketamine, suggests it acts as a prodrug. An extended-release tablet formulation could be effective and well-tolerated for TRD. Further research is needed to optimize dosing, evaluate long-term efficacy and safety, and understand the mechanisms underlying ketamine’s antidepressant effects in TRD.
The present phase 2 multicenter clinical trial was conducted across 20 psychiatric clinics in New Zealand, Australia, Singapore, and Taiwan. Following a 1-week open-label phase to exclude nonrespond.
