Volume 386, Issue 10011, Pages (December 2015)

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Volume 386, Issue 10011, Pages 2404-2412 (December 2015) Efficacy, safety, and tolerability of augmentation pharmacotherapy with aripiprazole for treatment-resistant depression in late life: a randomised, double-blind, placebo- controlled trial Prof Eric J Lenze, MD, Prof Benoit H Mulsant, MD, Daniel M Blumberger, MD, Jordan F Karp, MD, Prof John W Newcomer, MD, Prof Stewart J Anderson, PhD, Prof Mary Amanda Dew, PhD, Meryl A Butters, PhD, Jacqueline A Stack, MSN, Amy E Begley, MA, Prof Charles F Reynolds, MD The Lancet Volume 386, Issue 10011, Pages 2404-2412 (December 2015) DOI: 10.1016/S0140-6736(15)00308-6 Copyright © 2015 Elsevier Ltd Terms and Conditions

Figure 1 Trial profile MDD=major depressive disorder. The Lancet 2015 386, 2404-2412DOI: (10.1016/S0140-6736(15)00308-6) Copyright © 2015 Elsevier Ltd Terms and Conditions

Figure 2 Reduction in depressive symptoms during augmentation with aripiprazole or placebo Montgomery-Asberg Depression Rating Scale (MADRS) mean scores (bars show standard error of the mean so thatinference about the treatments can be visualised at each timepoint) plotted at the protocol-specified sampling times in the augmentation phase. Number of patients assessed at each time is shown at the bottom of the plot. Analyses used time as a continuous measure calculated using dates. Based on the Bayesian information criterion, a longitudinal mixed model with linear, quadratic, and cubic terms fit best. The mixed model data shows that both groups improved over time but the aripiprazole group showed a significantly greater improvement and includes linear and quadratic differences (linear × cell F=9·7, p=0·0019; quadratic × cell F=6·8, p=0·009). Based on the modelled data, the aripiprazole group decreases 7·6 points over 12 weeks whereas the placebo group decreases roughly 5·0 points over the same time period. The Lancet 2015 386, 2404-2412DOI: (10.1016/S0140-6736(15)00308-6) Copyright © 2015 Elsevier Ltd Terms and Conditions

Figure 3 Changes in cardiometabolic variables during augmentation with aripiprazole or placebo Mean total fat change (A) was +0·54 kg (SD 1·98) with aripiprazole (n=81) versus −0·06 (2·08) with placebo (n=83); p=0·064). Mean total weight change (B) was +1·93 kg (SD 3·00) with aripiprazole (n=84) versus +0·01 (3·15) with placebo (n=85); p<0·0001. The Lancet 2015 386, 2404-2412DOI: (10.1016/S0140-6736(15)00308-6) Copyright © 2015 Elsevier Ltd Terms and Conditions