Objective: To assess the effectiveness and safety of a treatment with sertraline (25-200 mg) in a prospective sample of institutionalized elderly depressed patients and the correlation between dose and clinical response.
Design: 298 institutionalized elderly patients outpatients with a depressive disorder were evaluated in a six-month, open-label, naturalistic, multicentric study conducted in Spain. Patients were assessed after 1, 3 and 6 months of treatment.
Materials and Methods: The main outcome measure were: Geriatric Depression Scale (GDS) (Yessavage, 15 item), Clinical Global Impression Scale of Severity (CGI-S), Clinical Global Impression Scale of Improvement (CGI-I), Mini Cognitive Examination (MCE) and Life Quality Questionnaire (LQQ). The statistic analysis included central tendency measures and dispersion for the quantitative variables, and absolute and relative frequencies for the categorical ones, Student’s t for paired dates to contrast changes in patient’s evolution between, both in absolute value and in percentage and Pearson’s Correlation Coefficient between studied variables and administered dose.
Results: Treatment was completed by 273 patients (92%). Four patients discontinued the treatment prior to the end of the study because of adverse events. The mean final daily dose was 65.7 mg/day (SD: ± 19.2 mg/day). Treatment resulted in a significant decrease of the GDS mean score (5,2 ± 2,8 points (p<0,0001)) from baseline to the final visit. The mean score of the CGI-S and CGI-I decreased 1,7 ± 1,0 points (p<0,0001) and 2,3 ± 0,8 points (p<0,0001) along the treatment. The mean MCE score decreased from 26,7 at baseline to 29,3 after 6 months of treatment. The difference was statistically significant (2,5 ± 4,6 (p<0,0001). LQQ presented an improvement (p<0,0001) in all 16 items of the scale. 98% of physicians and 86% of patients qualified as “good” or “excellent” treatment’s effectiveness. The results of the dose-response correlation with the main outcome measures was: negative lineal association between dose and mean GDS total score (more dose, less score in GDS) p<0,01; positive lineal association between dose and mean MCE score and mean LQQ total score (more dose, better score) p< 0,0003 and p< 0,0009. There was no statistic significance in the correlation between dose and CGI-S and CGI-I scales.
Conclusion: Sertraline is an effective and safety treatment in institutionalized elders with depression; The patients had an improvement in the cognitive function and quality of life along the treatment. The difference was statistically significant dose correlation with GDS, MCE and LQQ scales.
Back to Poster Session 1
Back to Oral and Poster Sessions
Back to The IPA European Regional Meeting (1-4 April 2003) of IPA