Up to 30 percent of people affected by severe depression find no relief despite medication. A large-scale international study sponsored by Janssen and conducted in scientific collaboration with University Hospital Frankfurt has now confirmed that esketamine nasal spray is superior to the type of therapy so far recommended in the National Disease Management Guidelines. The study’s primary manuscript was published in the New England Journal of Medicine on October 5, 2023.
Both severe depression and treatment-resistant depression are common. Up to one third of patients do not respond to conventional therapy with antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Treatment-resistant depression (in short TRD) leads to increased rates of comorbidity, suicide attempts and completions, all-cause mortality and hospitalization. In addition, the relapse rate among those affected is high, highlighting the need for effective and targeted therapies for TRD. Janssen Pharmaceutical Companies of Johnson & Johnson has recently completed an international randomized Phase IIIb study in scientific collaboration with University Hospital Frankfurt. The study compared the drugs and dosage forms of two combination therapies: One group was treated with SSRI/SNRIs in combination with esketamine nasal spray. In the comparison group, SSRI/SNRIs were administered together with quetiapine extended-release, as recommended by the National Disease Management Guideline on Unipolar Depression. The researchers established that the efficacy of esketamine nasal spray was superior in achieving remission at Week 8 (while still on study treatment) and in remaining relapse-free through Week 32 after remission at Week 8 (while still on study treatment) in patients who have TRD when both treatments were taken in combination with a continuing SSRI/SNRI.