Esketamin (1) – Spravato®

• Clinical trials
  • The pharmaceutical manufacturer identifies the two directly comparable, randomised clinical trials, TRANSFORM-2 and TRANSFORM-3. Both trials investigate acute treatment with esketamine versus placebo, in each case in combination with a newly initiated oral antidepressant from the SSRI or SNRI classes, over a treatment period of 28 days, plus screening and follow-up phases.

Adults with treatment-resistant major depression who have not responded to at least two different courses of antidepressant treatment during their current moderate to severe depressive episode

• For adults with treatment-resistant major depression who have not responded to at least two different courses of antidepressant treatment during their current moderate to severe depressive episode, the additional benefit is not proven.
• There are no studies comparing esketamine with the appropriate comparator therapy. The additional benefit is therefore not proven.
• Overall assessment
  • In summary, the TRANSFORM-2 and TRANSFORM-3 studies cannot be used to determine additional benefit due to the failure to implement the appropriate comparator therapy.
  • The comparison carried out is therefore not suitable for assessing additional benefit.

Courtesy translation only, please refer to the German original.