This completed Phase III feasibility trial (n=32) investigated the potential of ketamine to prevent postoperative depressive (PPD) symptoms in neurosurgical patients with a history of depression.
Conducted by the Washington University School of Medicine, the trial followed a randomised, placebo-controlled, double-blinded, parallel design. Patients received either a ketamine infusion or normal saline post-surgery and were assessed for depressive symptoms using the Montgomery-Asberg Depression Rating Scale (MADRS). The study aimed to assess the feasibility of conducting a full-scale phase III trial.
The primary outcomes included the fraction of approached patients who enrolled and were randomised, the fraction of randomised patients who completed the study infusion, and the fraction of randomised patients with MADRS scores at specified time points. Secondary outcomes included depressive symptoms and delta sleep ratio. The trial commenced on April 25, 2022, with a primary completion date of March 8, 2023. Recruitment took place at Washington University in St. Louis School of Medicine/Barnes-Jewish Hospital, Missouri, United States.
Trial Details
This protocol describes a feasibility trial that will evaluate the feasibility of conducting a full-scale phase 3 trial testing the hypothesis that a postoperative sustained, low-dose ketamine infusion can prevent postoperative depressive symptoms when administered to a targeted population of neurosurgical patients with a history of depression.NCT Number NCT05233566
Sponsors & Collaborators
Washington University School of MedicineLocated in St. Louis Missouri, researchers at the Washington University School of Medicine have conducted a number of studies with psychedelics inlcuding ketamine, psilocybin and nitrous oxide.