Ketamine for Adult Depression Study (KADS)

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.

Topic Treatment-Resistant Depression Depression
Compound Ketamine
Country Australia
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Trial Details



Trial Number

Sponsors & Collaborators

The University of New South Wales
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Papers

Economic evaluation of subcutaneous ketamine injections for treatment resistant depression: A randomised, double-blind, active-controlled trial - The KADS study
This cost-utility analysis, alongside a randomized controlled trial (n=174), compared subcutaneous ketamine (twice-weekly for 4 weeks) with midazolam in treatment-resistant depression. Including midazolam costs, ketamine raised QALYs (0.435 vs 0.352) and was dominant with an 89–91 % chance of costing < $50 000/QALY, but once these comparator costs were excluded ketamine was no longer cost-effective (ICER ≈ $108 500–$251 250/QALY, ≤ 5 % probability).

Effect of ketamine on anxiety: findings from the Ketamine for Adult Depression Study
This secondary analysis of a Phase III trial (n=174) evaluates the effects of subcutaneous ketamine on anxiety in treatment-resistant depression (TRD). Significant reductions in anxiety (HAM-A scores) were observed in cohort 2 with flexible dosing (35-63mg/70kg) but not in cohort 1 with fixed low dosing (35mg/70kg). These effects, mediated by changes in depression (MADRS), were not sustained 4 weeks post-treatment.

Efficacy and safety of a 4-week course of repeated subcutaneous ketamine injections for treatment-resistant depression (KADS study): randomised double-blind active-controlled trial
This 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.

Data attribution

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