Using Aripiprazole in Major Depressive Disorder

Leslie Citrome, MD, MPH


November 06, 2013

Aripiprazole Augmentation for Major Depressive Disorder: Dosing Patterns in a Naturalistic Treatment Setting

Pae CU, Wang SM, Han C, Lee SJ, Patkar AA, Masand PS
Int Clin Psychopharmacol. 2013 Oct 8. [Epub ahead of print]

Study Summary

This study reported dosing patterns for aripiprazole augmentation for major depressive disorder in a naturalistic treatment setting. The records of a total of 276 patients were reviewed. The mean duration of aripiprazole augmentation was approximately 5 months; the mean time to the first increase of aripiprazole was about 3 weeks; and the mean initial, first uptitrated, maximal, and maintenance doses were 3.4, 4.2, 4.7, and 4.4 mg/day, respectively.


In the US Food and Drug Administration (FDA)-approved product labeling for aripiprazole, the recommended initial dose for use as an adjunct to antidepressants for the treatment of major depressive disorder in adults is 2-5 mg/day. The recommended target dose is 5-10 mg/day, with a maximum recommended dose of 15 mg/day. These recommendations are a consequence of the design of the clinical trials that were used to garner regulatory approval by the FDA. In those trials, the dosage of aripiprazole was flexible, starting at 5 mg/day and adjusted within the range of 2-20 mg/day. The mean final dose was 11-12 mg/day in the 3 available studies. The median dose was 10 mg/day, and the modal dose was 5 mg/day.

Pae and colleagues observed that in the "real world," aripiprazole dosing for the treatment of major depressive disorder is lower than what was originally believed to be necessary. Anecdotally, this is consistent with my own practice, where initial dosing for aripiprazole can range from 1-2.5 mg/day, with titration up to 5 mg/day as needed.



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