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

Abstract

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-SOM) 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-SOM 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-SOM 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. Trial Registration: https://cris.nih.go.kr ; identifier: KCT0004607.

The Potential Role of Aripiprazole Augmentation for Major Depressive Disorder with Anxious Distress in Naturalistic Treatment Setting

“…Untreated residual anxiety symptoms are consistently found to be a definite huddle in achievement of sufficient clinical outcome in MDD in past studies [ 28 , 29 ]. In a recent study investigating the effect of ARPA for MDD patients with somatic symptoms, the decrease of Beck Anxiety Inventory score was also approximately 3 points, which is quite similar with our finding [ 30 ]. In addition the mean number of antidepressant change was almost 3 in our study corresponding to the level 3 of Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial which has shown that the treatment effects are substantially decreased by failure of treatment [ 31 ].…”

“…Another point is that the mean dose of ARPA for MDDA was low ranging 1.6 mg/d to 1.9 mg/d, not greater than 2 mg/d, which is in line with Japanese controlled trial for MDD [ 32 ] where 3 mg/d of ARPA was equal or greater in treatment outcomes vs. 9.8 mg/d group. The mean dose of ARP was also 3 mg/d in a recent trials for MDD patients with somatic symptoms [ 30 ]. We may carefully assume that low dose of ARP should be adequate for subpopulation of MDD based on above findings.…”

Use of the Third-Generation Atypical Antipsychotic Aripiprazole (Zylaxera®) for Treatment of Depressive States in Schizophrenia: Efficacy and Safety Study

“…Так, в частности, проводилось РКИ, где сравнивали динамику выраженности симптомов соматизации по шкале SCL-90-R у пациентов с депрессией, получающих в дополнение к антидепрессанту арипипразол, в сравнении с группой контроля, получавшей плацебо. В исследуемой группе выраженность соматических симптомов значимо снизилась, клиническое улучшение при этом коррелировало с уменьшением выраженности альфа-ритма в лобных долях и в целом на ЭЭГ [41]. В еще одном РКИ показано, что у пациентов, получавших арипипразол в комплексной терапии монополярной депрессии, снижался суицидальный риск [42].…”