This interventional trial (n=200) aimed to assess the effectiveness of ketamine therapy among patients with treatment-resistant depression in a double-blind, randomised, controlled setting.
Led by the University of New South Wales, the study involved administering ketamine via subcutaneous injection twice weekly for 4 weeks in each phase. The trial included a 4-week randomized controlled phase followed by a 4-week open-label extension phase, with a 1-month break in between.
The primary outcome measure was remission at the end of the randomized controlled phase, assessed using the Montgomery Asberg Depression Rating Scale (MADRS). Secondary outcomes included changes in MADRS score, depression severity assessed using the Clinician Global Impressions-Severity (CGI-S) scale, anxiety levels measured by the Hamilton Anxiety Rating Scale (HAM-A), and other measures related to depression severity, suicidality, psychotomimetic symptoms, quality of life, and biomarkers.
The trial aimed to determine the safety, tolerability, feasibility, sustained antidepressant benefits, and cost-effectiveness of repeated ketamine doses in outpatient settings.
Recruitment for the trial was completed, with 183 participants enrolled across multiple sites in Australia and New Zealand. The trial’s principal investigator is Prof. Collen Loo, and Dr. Angelo Alonzo.
Trial Details
Ketamine. During 4-week RCT and 4-week open label extension phase with 1 month break between the two phases, A follow up is scheduled 1 month after the end of RCT where participants will be further screened for eligibility (as per RCT criteria) to enter the open label phase with the only difference being that participants are not blinded to the drug administered.NCT Number ACTRN12616001096448
Sponsors & Collaborators
The University of New South WalesThis company doesn't have a full profile yet, it is linked to a clinical trial.
Papers
Efficacy and safety of a 4-week course of repeated subcutaneous ketamine injections for treatment-resistant depression (KADS study): randomised double-blind active-controlled trialThis Phase III, double-blind, randomized trial (n=174) evaluated the acute efficacy and safety of a 4-week course of ketamine (35-63mg/70kg) in participants with treatment-resistant depression (TRD). The study found that ketamine was more efficacious than midazolam (1.75mg/70kg) in the flexible-dose cohort (remission rate 19.6% vs 2.0%), demonstrating that adequately dosed subcutaneous racemic ketamine is both effective and safe in treating TRD over 4 weeks.