By Vijay Kumar MalesuReviewed by Susha Cheriyedath, M.Sc.Jun 26 2024 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 in adult patients with treatment-resistant depression through a randomized placebo-controlled phase 2 trial.
About the study 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 nonresponders, a 12-week double-blind phase assessed responders. The trial adhered to ethical standards and was registered .
The primary endpoint was the change in MADRS score from baseline to day 92, analyzed using analysis of covariance. Safety assessments included lab tests, Electrocardiograms , cognitive tests, and adverse event reports. The sample size aimed for significant MADRS score improvement with R-107 compared to placebo, involving 200 initial participants to ensure 150 randomized.
Related StoriesBy the end of the study , 100 participants had discontinued, 94 of whom were due to a lack of efficacy . Discontinuations were distributed as follows: placebo , 30 mg , 60 mg , 120 mg , and 180 mg . Completion rates ranged from 29.7% in the placebo group to 56.2% in the 180 mg group, with higher completion rates associated with higher R-107 doses. Treatment compliance was high, with 96.4% of participants reporting 80% or more compliance.