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Major depressive disorder (MDD) is a common and recurrent mental disorder with a lifetime prevalence of approximately 16%1,2 that results in high levels of disability worldwide.3 Persistent depressive symptoms lead to reduced overall function and quality of life and increased risk of suicide.4,5 Therefore, early detection and appropriate interventions for depression are important. Moreover, a significant association between the duration of a depressive episode and prognosis has been reported.5,6 Early improvement of symptoms increases treatment compliance and reduces exposure to suicidality.7 However, in more than half of cases, the first-line antidepressant treatment does not show sufficient effect.8 One recommended treatment in these cases is augmentation with second-generation antipsychotic drugs9,10 with proven efficacy, including aripiprazole, quetiapine, and olanzapine.11 However, few studies have assessed when these treatments begin to show significant therapeutic effects in patients with depression.
This study investigated the early effectiveness of adjunctive aripiprazole treatment on clinical symptoms and quality of life, especially which symptom elements improved earlier, in patients with MDD.
Methods
Study Design
This study was conducted at the Seoul National University Hospital in South Korea between January 2012 and October 2016. After study enrollment, the subjects were randomly assigned to either the early or delayed treatment group using a table of random numbers. The early treatment group received adjunctive aripiprazole treatment in the first week of the study, while the delayed treatment group received adjunctive aripiprazole treatment in the third week of the study. Ongoing standard antidepressant treatment was continued and the doses were fixed during the study in all patients. The total study period was 8 weeks. The study was single-blinded, with the rater unaware of the group allocations. Patient codes were handled by a well-trained researcher and anonymity was maintained until the last patient evaluation. The study medication was administered once daily. The starting dose of aripiprazole was 1–2.5 mg/day, which could be increased up to 20 mg/day based on clinical judgment. A pill count was performed at every visit to evaluate compliance with the medication regimen. Patients reporting an interruption of aripiprazole for 7 or more days or reporting an intake of <50% of the dosage over two consecutive weeks were withdrawn from the study. Lorazepam, zolpidem, benztropine, trihexyphenidyl, and propranolol...