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Context: Expert guidelines recommend that the pharmacological treatment of major depression with psychotic features (MDpsy) combines antidepressant with antipsychotic medications. However, evidence for the efficacy of combination pharmacotherapy has been limited and without positive trials in geriatric patients. Objective: (1) Compare remission rates in MDpsy associated with combination atypical antipsychotic medication plus a serotonin-reuptake-inhibitor antidepressant (SSRI) to remission associated with antipsychotic monotherapy; (2) Compare the efficacy and tolerability of treatment in younger versus older adults. Design and Context: Twelve-week double-blind randomized controlled comparison of olanzapine plus sertraline to olanzapine plus placebo conducted on clinical services of four academic sites. Patients and Interventions: 259 subjects with MDpsy randomized by age ≥60 on a 1:1 basis; mean age of 117 younger adults = 41.3(10.8) versus 71.7(7.8) in 142 geriatric participants; target doses of olanzapine 15-20 mg/day plus masked sertraline or placebo at 150-200 mg/day. Results: Olanzapine/sertraline was associated with a higher remission rates over the trial than olanzapine/placebo (OR=1.28, 95% CI =1.12-1.47, p<.001). 41.9% of combination subjects were in remission at their last assessment compared to 23.9% of olanzapine monotherapy subjects (χ21= 9.53, p=.002). Combination therapy was comparably superior in younger adult (OR=1.25, 95% CI =1.05-1.50, p=.02) and older subjects (OR=1.34, 95% CI =1.09-1.66, p=0.01). Secondary efficacy measures also supported combination treatment. Overall tolerability was comparable across age groups, with age-related differences in specific side effects. Both age groups had significant increases in cholesterol and triglyceride levels, but statistically significant increases in glucose occurred only in younger adults (t=2.76, df=205, p=.01). Although both age groups experienced significant weight gain, younger adults gained significantly more weight (14.5±14.7 versus 7.3±10.9 pounds, F=11.10, df=1,221, p=.001). Conclusions: Combination pharmacotherapy is efficacious for the treatment of MDpsy. Future research must determine the benefits of continuing atypical antipsychotic medications beyond twelve weeks against the associated metabolic effects. Trial Registration and URL: Clinicaltrials.gov Registry ID: NCT00056472

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