Agomelatine in Standard Medical Practice in Depressed Patients: Results of a 1-Year Multicentre Observational Study In France

Abstract

Background and Objectives Non-interventional studies are a valuable source of evidence that is complementary to traditional randomised, blinded and controlled clinical trials, for evaluating antidepressants in a real-world setting. The aim of the present study was to document the use of agomelatine in current medical practice and evaluate its effectiveness and safety in outpatients prescribed agomelatine to treat their current depressive episode. Methods This 12-month observational French study included patients initiating agomelatine treatment. The intensity and severity of depression were assessed using the 17-item Hamilton Depression Rating Scale (HAM-D17) total score and the Clinical Global Impression-Severity of Illness (CGI-S) scale. Patients’ quality of life and functioning were measured using the Quality of Life in Depression Scale and the Sheehan Disability Scale, respectively. The safety measures included emergent adverse events and biological samplings, with a focus on liver acceptability. Results A total of 1484 patients (70% of women; 49.6 ± 15.4 years of age) were enrolled in the study. Most patients (62.3%) were treated with agomelatine for at least 6 months and 28.8% were treated for at least 1 year. Mean HAM-D17 total score and mean CGI-S scores decreased by 13.6 ± 8.1 and 2.1 ± 1.5 points, respectively, from baseline to last visit on agomelatine. Rates of responders (i.e. with a decrease in HAM-D17 total score by at least 50%) and remitters (HAM-D total score < 7) at the last visit were 90.7% and 56.0%, respectively. The mean HAM-D total score decreased after agomelatine withdrawal (− 4.1 ± 6.7) until the last visit. The quality of life and daily functioning of patients improved, while the numbers of days lost and underproductive days decreased over the follow-up period. Safety findings were in accordance with the known information regarding agomelatine. Conclusion In the current medical practice, this study confirms the effectiveness and good tolerability of agomelatine administered for a treatment period in agreement with guideline recommendations. Trial registration number ISRCTN53570733 on 27 August 2010.

Adherence to antidepressant therapy: clinical experience on the example of agomelatine

“…Данные неинтервенционного исследования, направленного на изучение эффективности и переносимости агомелатина в современной медицинской практике во Франции [20], подтвердили результаты имеющихся рандомизированных клинических исследований. Повышение дозы агомелатина до 50 мг потребовалось 18,3% пациентов, что О Б З О Р Ы Неврология, нейропсихиатрия, психосоматика.…”

“…1. Изменение клинико-шкальных показателей у пациентов, получавших агомелатин, за период наблюдения [20]. М -среднее, SD -стандартное отклонение Fig.…”

“…По запросу Комитета по обеспечению прозрачности Французского национального агентства по оценке медицинских технологий (Transparency Committee of the French National Health Technology Assessment Authority, HAS) было проведено исследование безопасности и эффективности агомелатина в реальных клинических условиях. В рамках проспективного наблюдательного многоцентрового когортного исследования на протяжении одного года в динамике терапии агомелатином изучали выраженность депрессии и частоту рецидивов, влияние лечения на социальное функционирование и качество жизни пациентов, продолжительность лечения и его безопасность [20]. В исследование вошло 1484 пациента (70% -женщины, возраст -49,6±15,4 года).…”

Función Protectora De La Melatonina Durante El Ejercicio Físico

“…Podemos considerar a la melatonina como una molécula con utilidad clínica emergente, ya que sus múltiples propiedades beneficiosas, antioxidante, antiinflamatoria, analgésica y antitumoral, y la ausencia de efectos tóxicos reseñables están haciendo que sea ampliamente estudiada su aplicabilidad en la prevención y tratamiento de múltiples trastornos. Hasta el momento hay evidencia de su efectividad en el tratamiento del insomnio, de varios tipos de cáncer, de la hipertensión arterial (Scheer et al, 2004), de la depresión mayor y de trastornos de ansiedad (Gorwood et al, 2020), y se están realizando estudios sobre su posible aplicación en el abordaje del ictus, de las lesiones cerebrales en recién nacidos pretérmino y de enfermedades neurodegenerativas como el Alzheimer, el Parkinson, la enfermedad de Huntington y la esclerosis lateral amiotrófica (Tordjman et al, 2017). Otra vía de investigación abierta con la melatonina es su relación con el ejercicio físico y los posibles beneficios que puede reportar su administración exógena en la disminución del estrés oxidativo que comporta su práctica y en la mejora del rendimiento deportivo.…”

Assessing the meaningful change threshold of Quality of Life in Depression Scale using data from two phase 3 studies of esketamine nasal spray

“…The Quality of Life in Depression Scale (QLDS) is a disease-specific patient-reported questionnaire designed to assess the impact of depression on the HRQoL of patients [16]. The QLDS has been shown to have high reliability and construct validity [17], has been translated into multiple languages [18], and has been used in clinical trials and observational studies for the past 2 decades [19][20][21][22][23][24][25][26][27]. However, it is important to understand whether the results from a PRO are meaningful from the patients' perspective.…”