Efficacy of aripiprazole as adjunctive therapy in major depressive disorder with somatic symptoms: A randomized, double-blind, placebo-controlled trial with clinical and electroencephalography evidence

초록

Background: Somatic symptoms, which are common in major depressive disorder (MDD), are associated with a worse prognosis and increased health costs. Aims: This randomized, double-blind, placebo-controlled study evaluated the efficacy of aripiprazole augmentation in MDD patients with somatic symptoms. Methods: In all, 41 MDD patients with somatic symptoms completed the study. Participants who had been on a stable dose of antidepressants for at least 1 month were randomly assigned to receive an 8-week adjunctive treatment with either aripiprazole or placebo. The initiation dose of aripiprazole was 2 mg/day, which was later adjusted to 1-10 mg/day. The primary endpoint was the change in the Symptom Checklist-90-Revised-Somatization (SCL-90-R-S0M) score. We collected quantitative electroencephalogram data and performed spectral analyses to obtain the absolute power of frequency bands. Results/outcomes: The aripiprazole group (n=20; 2.98 +/- 1.75 mg/day) showed a significant improvement in SCL-90-R-S0M scores compared to the placebo group (n=21; F=8.56, p=0.006), without significant differences in changes in depression and anxiety symptoms. Compared to the control, the aripiprazole group showed a greater decrease in total alpha power (F=7.03, p =0.01). Changes in frontal alpha power were positively correlated with changes in SCL-90-R-S0M scores in the aripiprazole group (r=0.53, p=0.014). Conclusions/interpretation: Aripiprazole adjunctive to antidepressants in patients with MDD and somatic symptoms improved somatic symptom severity without significant safety concerns, and this improvement correlated with a decrease in total and frontal alpha power.

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