Continuing olanzapine plus sertraline compared with sertraline alone reduces risk of relapse with psychotic depression

Reference

Flint AJ, Meyers BS, Rothschild AJ, et al. Effect of continuing olanzapine vs placebo on relapse among patients with psychotic depression in remission. The STOP-PD II randomized clinical trial. JAMA 2019;322(7):622-31.

Synopsis

Treating psychotic depression includes both an antidepressant and antipsychotic medication. However, it remains uncertain as to whether outcomes are improved by continuing both medications after patients are in remission. These investigators identified patients, aged 18 to 85 years, meeting standard diagnostic criteria for major depression with associated delusions. Study participants (n = 269) initially received sertraline (target dose, 150-200 mg/d) plus olanzapine (target dose, 15-20 mg/d) for up to 12 weeks. Those patients (n = 126) meeting criteria for stable remission or near remission (rated as very much improved) for 8 weeks randomly received (concealed allocation assignment) either continued sertraline and olanzapine or sertraline and placebo. Follow-up occurred for all participants at 36 weeks, with 90.5% of randomized participants completing the trial. Individuals assessing outcomes remained masked to treatment group assignment. Using intention-to-treat analysis, Relapse occurred in significantly fewer patients in the sertraline-olanzapine group compared to the sertraline-placebo group (20.3% vs 54.8%, NNT= 2.9; 95% CI, 2.1-5.6). Adverse effects mainly including weight gain occurred more often in the sertraline-olanzapine group (17.2% vs 4.8%). The incidence of akathisia and tardive dyskinesia was similar in both groups.