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Aripiprazole Boosts Efficacy of Antidepressants in Older Patients With Major Depressive Disorder: Presented at AAGP

By Emma Hitt, PhD

HONOLULU -- March 7, 2009 -- Adjunctive aripiprazole appears to be effective in relieving the symptoms of depression in patients aged 50 years or older, according to research presented at the American Association for Geriatric Psychiatry (AAGP) 22nd Annual Meeting.

J. Craig Nelson, MD, University of California San Francisco School of Medicine, San Francisco, California, and colleagues presented the findings here on March 6. According to the researchers, the treatment effect of selective serotonin-reuptake inhibitors is generally minimal in elderly patients with major depressive disorder. The current study sought to determine whether adjunctive aripiprazole might benefit this population when added to standard antidepressant treatment.

Aripiprazole is an atypical antipsychotic currently approved for use only as an adjunct to antidepressant medication.

In a subgroup analysis of patients aged 50 years or older, data were pooled from 3 identical aripiprazole augmentation studies. Patients were treated for 8 weeks with the antidepressant alone. Responders continued on antidepressants, while nonresponders were randomised to receive 6 additional weeks of antidepressant therapy in combination with either placebo (n = 198) or aripiprazole (n = 211).

The mean dose of adjunctive aripiprazole was 9.9 mg/day. Significantly greater improvement in the Montgomery-Åsberg Depression Rating Scale total score in the aripiprazole arm was observed as early as the first week of double-blind treatment (-3.99 vs -2.66; P = .009) through week 14 of treatment.

At week 14, both the response rate and remission rate were significantly greater with aripiprazole versus placebo. The response rates were 39.7% versus 24.4% (P = .001), and the remission rates were 32.5% versus 17.1% (P = .0004) for the aripiprazole versus placebo groups, respectively.

In the oldest group of patients, aged 61 years or older, the response rates were 56.63% versus 17.65% and the remission rates were 42.11% versus 14.71% for the aripiprazole versus placebo groups, respectively (P < .001 for both).

The most common adverse events occurring more frequently with aripiprazole than placebo were akathisia (17.1%), restlessness (13.3%), somnolence (8.6%), and insomnia (8.1%).

"In a population that can be sensitive to extrapyramidal symptoms and somnolence-related effects of neuroleptic agents, adjunctive aripiprazole was relatively well tolerated and safe, as evidenced by the high completion rate and low rate of discontinuation due to adverse events," Dr. Nelson's team concluded.

Prospective studies, especially for patients aged 65 years or older are needed, they added.

Funding for the study was provided by Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd.


[Presentation title: Subpopulation Analysis of Adjunctive Aripiprazole in MDD Patients Aged =>50 years (CN138-139/163/165). Abstract NR 7]

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