Four-week course efficacious and safe for treatment-resistant depression<\/p>\n<\/h3>\n
By Elana Gotkine HealthDay Reporter<\/b><\/p>\n
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FRIDAY, July 21, 2023 (HealthDay News) — A four-week treatment course of racemic ketamine is efficacious and safe for treatment-resistant depression (TRD), according to a study published online July 14 in the British Journal of Psychiatry<\/em>.<\/p>\n Colleen Loo, M.B.B.S., M.D., from the University of New South Wales in Randwick, Australia, and colleagues examined the acute efficacy and safety of a four-week course of subcutaneous racemic ketamine in patients with TRD in a double-blind, randomized, multicenter trial. Participants received twice-weekly subcutaneous racemic ketamine or midazolam for four weeks. Fixed-dose ketamine 0.5 mg\/kg versus midazolam 0.025 mg\/kg was tested initially (cohort 1; 68 patients); after a Data Safety Monitoring Board recommendation, dosing was revised to flexible-dose ketamine 0.5 to 0.9 mg\/kg or midazolam 0.025 to 0.045 mg\/kg, with response-guided dosing increments (cohort 2; 106 patients).<\/p>\n The researchers found that ketamine was more efficacious than midazolam in cohort 2 (remission rate, 19.6 versus 2.0 percent; odds ratio, 12.1; 95 percent confidence interval, 2.1 to 69.2; P = 0.005), but not in cohort 1 (remission rate, 6.3 versus 8.8 percent; odds ratio, 1.3; 95 percent confidence interval, 0.2 to 8.2; P = 0.76). Ketamine was tolerated well. Acute adverse effects resolved within two hours.<\/p>\n “Racemic ketamine, given by subcutaneous injection at adequate doses, is safe and efficacious in the therapy of treatment-resistant depression over a four-week treatment course,” the authors write. “Benefits attenuate after treatment cessation for most patients, supporting prior evidence that ketamine should be considered as a longer-term treatment.”<\/p>\n Several authors disclosed ties to biopharmaceutical companies; one author is named on a patent for a controlled release ketamine tablet developed by Douglas Pharmaceuticals.<\/p>\n