The Daily Functionality in a Major Depressive Episode Cohort of Romanian Patients - a Non-Interventional Study.

OBJECTIVES The aim of this non-interventional, investigator driven study was to assess the functionality of patients with major depression under treatment with agomelatine in real life clinical practice. MATERIAL AND METHODS The study was multicenter, non-interventional and evaluated the functionality of the adult patients with a DSM-IV diagnosis of MDD (single or recurrent episode and no treatment in the previous 6 months). It took place in Romania and it was a 10-weeks study. After the clinicians took the medical decision of treatment with agomelatine and if the patient agreed to be evaluated more accurate in this study, in order to assess functionality, patients completed at each visit the Sheehan Disability Scale (SDS). Patients were assessed also with QIDS-C (Quick Inventory of Depressive Symptomatology), a measure of depression symptoms severity and CGI scale severity (CGI-S), CGI scale improvement (CGI-I) and therapeutic index. Also, data about demographics and disease were collected during clinical interviews and from medical records. RESULTS The functionality as assessed with SDS showed a significant functional impairment at baseline with scores >6 for each of the 3 inter-related domains of work/school, social and family life. At the end of the study, all functional aspects were improved although a mild impairment still persist requiring further treatment. A total of 1191 patients were analyzed (mean age: 47 years, 68% female). Mean QIDS-16 total score at baseline was 14.3 and decreased over the 10-week prospective period to 2.3. Most patients were treated with agomelatine. CONCLUSION This study outcome confirms the fast on set of functionality improvement of agomelatine and further treatment need for the total remission of clinical depressive symptomatology after 10 weeks of treatment.