Research library / Clinical trial
Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial
Daly EJ, Trivedi MH, Janik A, et al. JAMA Psychiatry 2019;76(9):893-903
Clinical trialKetaminetreatment-resistant depression
This trial asked whether people with treatment-resistant depression who improved on esketamine nasal spray should keep taking it. 705 adults started esketamine plus an oral antidepressant; 297 who were doing well after 16 weeks were randomly assigned to continue esketamine or switch to a placebo spray. Among those in remission, about 27% relapsed on esketamine against 45% on placebo; among those who had responded without full remission, 26% against 58%. The authors conclude that continuing esketamine delays relapse in people who respond to it.
What it found
- Among people in stable remission, 26.7% relapsed if they continued esketamine and 45.3% if they switched to placebo (hazard ratio 0.49; number needed to treat 6)
- Among people with a response but not remission, 25.8% relapsed on esketamine against 57.6% on placebo (hazard ratio 0.30; number needed to treat 4)
- The most common side effects were altered taste, vertigo, dissociation, sleepiness and dizziness (20.4% to 27.0%)