RESUMO
OBJECTIVES: An open 4-month evaluation of the effectiveness, tolerability and safety of venlafaxine XR in the treatment of outpatients with major depression. MATERIAL AND METHODS: We conducted a multi-center, open, not placebo-controlled, phase IV clinical trial. Participants had to be outpatients, female or male, between 18 and 66 years of age, with a diagnosis of major depressive disorder according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-IV) and a minimal score of 20 points on the 21-item Hamilton Scale for Depression (HAM-D21). No patients with a deteriorated condition participated in this study. The evaluations confirmed the physical conditions of all participants as well as the application of HAM-D21 and Clinical Global Impressions (CGI) for up to 4 months. The doses managed for venlafaxine XR started with 75 mg/day, which was increased in the same proportion up to a maximum dose of 225 mg/day, depending on medical judgment. Descriptive statistics were used, t paired for HAM-D21 and CGI. RESULTS: 96 patients were recruited and participated in this study, 74 patients completed the study. Baseline score for HAM-D21 was 30.9 +/- 5.5 and the score for the final visit was 4.9 +/- 6.1 (95% CI, p < .0001). Baseline CGI score of 4.6 +/- 1.2 and final CGI score of 1.5 +/- 0.9 (95% CI p < .0001), between baseline and final visit. The most frequent adverse events in a descending order were dry mouth, nausea, headache, somnolence, and dizziness. Five adverse events were catalogued and reported as serious adverse events. Patients did not show any modifications in laboratory analysis results, vital signs or weight. CONCLUSION: This open evaluation of venlafaxine XR in a Mexican population shows the effectiveness, good tolerability and safety of venlafaxine XR in the treatment of depression.