This paper reports the findings from a 52-week, open-label trial that assessed the long-term safety and tolerability of aripiprazole adjunctive to antidepressant therapy. Assessment of tolerability was the primary objective of this study, and was evaluated by spontaneous reporting of adverse events, assessment of extrapyramidal symptoms using objective rating scales, and assessment of changes in body weight, fasting plasma lipids, and glucose levels. Specific efficacy findings from this long-term, open-label safety extension phase are also presented. Eligible patients included those who had been previously treated with adjunctive aripiprazole or placebo in two of the previous short-term trials,5,6 as well as de novo subjects with a documented inadequate response to standard antidepressant therapy.
Marler, Sabrina Vogel; Berman, Robert M.; Thase, Michael E.; Trivedi, Madhukar H.; McQuade, Robert D.; Carson, William; Baker, Ross A.; and Marcus, Ronald N., "Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder." (2011). Faculty Publications. Paper 24.