Pedro Damian Gargoloff1,2, Ricardo Corral3, Luis Herbst4, Miguel Marquez5, Giovanni Martinotti6, Pedro Rafael Gargoloff2. 1. Hospital Alejandro Korn, Melchor Romero, La Plata, Argentina. 2. Clinica City Bell, La Plata, Argentina. 3. Departamento de Docencia e Investigacion, Hospital Jose T Borda, CABA, Argentina. 4. Hospital Jose T. Borda, CABA, Argentina. 5. ADINEU, CABA, Argentina. 6. Department of Neuroscience, Imaging and Clinical Science, Chieti, Italy.
Abstract
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.
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.
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