Human psychopharmacology · 2016
Effectiveness of agomelatine on anhedonia in depressed patients: an outpatient, open-label, real-world study.
Клиническое исследование IV фазыСтатьяМногоцентровое исследованиеPragmatic Clinical TrialНазвание и аннотация: Перевод пока не подготовлен
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Gargoloff Pedro Damian, Corral Ricardo, Herbst Luis, Marquez Miguel, Martinotti Giovanni, Gargoloff Pedro Rafael
Аннотация
OBJECTIVE: The aim of this real-world study was to evaluate the effect of agomelatine on anhedonia as primary endpoint in outpatients under treatment of major depressive episodes.
METHODS: The study was an open-label, multicenter, 8-week phase IV trial. Two hundred fifty-seven (257) patients were recruited, and 143 patients were included in the analysis. Agomelatine was administered orally as a 25-mg tablet. The dose could be increased to 50 mg after 2 weeks of treatment.
RESULTS: An improvement in the severity of anhedonia (Snaith-Hamilton Pleasure Scale total score) was observed from 8.5 points at baseline to 4.1 at week 8, statistically significant (p < 0.05) from the first week. Significant decreases in scores on the severity of depression (Quick Inventory of Depressive Symptomatology 16-item Self-Report [QIDS-SR-16]), anxiety (Generalized Anxiety Disorder 7-item scale), and in overall clinical status (CGI) were also found over 8 weeks, independently from the presence of a first or recurrence episode. Response (QIDS-SR-16 score ≥ 50% of baseline) at week 8 was observed in 65.7% of the patients, while 49.6% of the patients achieved remission (QIDS-SR-16 score ≤ 5).
CONCLUSION: Agomelatine was shown to be effective on anhedonia, depression, and anxiety in subjects with major depression. The pragmatic design of the study reflects real-world clinical practice providing interesting insights into routine care management.
METHODS: The study was an open-label, multicenter, 8-week phase IV trial. Two hundred fifty-seven (257) patients were recruited, and 143 patients were included in the analysis. Agomelatine was administered orally as a 25-mg tablet. The dose could be increased to 50 mg after 2 weeks of treatment.
RESULTS: An improvement in the severity of anhedonia (Snaith-Hamilton Pleasure Scale total score) was observed from 8.5 points at baseline to 4.1 at week 8, statistically significant (p < 0.05) from the first week. Significant decreases in scores on the severity of depression (Quick Inventory of Depressive Symptomatology 16-item Self-Report [QIDS-SR-16]), anxiety (Generalized Anxiety Disorder 7-item scale), and in overall clinical status (CGI) were also found over 8 weeks, independently from the presence of a first or recurrence episode. Response (QIDS-SR-16 score ≥ 50% of baseline) at week 8 was observed in 65.7% of the patients, while 49.6% of the patients achieved remission (QIDS-SR-16 score ≤ 5).
CONCLUSION: Agomelatine was shown to be effective on anhedonia, depression, and anxiety in subjects with major depression. The pragmatic design of the study reflects real-world clinical practice providing interesting insights into routine care management.