Oral prolonged-release ketamine in treatment-resistant depression - A double-blind randomized placebo-controlled multicentre trial of KET01, a novel ketamine formulation - Clinical and safety results.
Journal of psychiatric research May 1, 2024 M Colla, B Offenhammer, H Scheerer et al. 23 citations
A novel oral prolonged-release formulation of racemic ketamine (KET01) was tested as an add-on therapy for treatment-resistant depression. Patients received 160 mg/day, 240 mg/day, or placebo for 14 days. The 240 mg/day group showed a numerically larger but statistically non-significant improvement in depression scores compared to placebo. The trial was terminated early due to poor recruitment during the COVID-19 pandemic, with only 27 patients completing the protocol. Adverse event rates were similar across groups, and no increased risk of suicidality, dissociation, or blood pressure changes was observed. Baseline leukocyte count correlated with response to KET01 in exploratory analysis.