An open trial of aripiprazole augmentation for SSRI non‐remitters with late‐life depression

Abstract

To evaluate the efficacy and tolerability of aripiprazole augmentation in elderly depressed patients who did not reach remission after treatment with an SSRI. Outpatients 50 years and older with major depressive disorder not remitting after adequate treatment with an SSRI were eligible for the study. In the 6-week long augmentation phase, antidepressants were continued without change and aripiprazole was titrated if needed to a maximum dose of 15 mg per day. Patients were evaluated at the study endpoint on an intent to treat basis, and the primary outcome measure was remission of depression as measured by Hamilton Rating Scale for Depression (HRSD) <or= 10. Twenty patients having mean age 63.0 +/- 9.6 years old, HRSD 20.0 +/- 4.2, Beck Depression Inventory (BDI) 21.0 +/- 9.8, Clinical Global Impression-Severity (CGI-S) 3.7 +/- 0.9, and Mini Mental State Examination (MMSE) 29.2 +/- 1.0 entered the study. At the study endpoint, mean HRSD was 7.6 +/- 5.9, BDI 9.1 +/- 9.3, and CGI-S 1.9 +/- 1.1. A 50% remission rate of depression was observed after six weeks of augmentation with aripiprazole. Twenty five percent of subjects did not complete the study. The most frequent side effects observed were dry mouth (25%), agitation/anxiety (20%), and drowsiness (15%). In this study 50% of depressed patients not remitting after an adequate trial of an SSRI achieved a final HRSD <or= 10 when given aripiprazole augmentation. Open trials such as this require follow up in a randomized, placebo-controlled trial.