The study of correlation between depression, quality of life and glycemic control in a sample of Iranian diabetic patients (original) (raw)
2008, European Psychiatry
(n¼151) and placebo (n¼157). Primary endpoint: baseline to Week 6 change in MADRS total score. Secondary variables included: baseline to Week 6 change in HAM-D total and Item 1 (depressed mood) scores. Safety assessments included AE reporting. Results: Mean MADRS total score (overall baseline mean, 30.15) was significantly reduced at Week 6 by quetiapine XR 150mg/day, 300mg/day and duloxetine versus placebo (À14.81, À15.29, À14.64, À11.18, respectively; p 0.001). At Week 6, mean HAM-D total scores (overall baseline mean, 25.25) were significantly reduced versus placebo (À10.26) by quetiapine XR 150mg/day, 300mg/day (À13.12, À14.02, respectively, p 0.001) and duloxetine (À12.37, p<0.05). Mean HAM-D item 1 scores (overall baseline mean, 3.03) were significantly reduced versus placebo (À1.07) by quetiapine XR 150mg/day, 300mg/day (À1.49, À1.56, respectively, p 0.001) and duloxetine (À1.53, p<0.001). Incidence of serious AEs were low (2%) in all groups. Most common AEs (>10%) were dry mouth, sedation, somnolence, dizziness, headache and nausea with quetiapine; dizziness and headache with placebo; and dry mouth, sedation, somnolence, dizziness, headache, constipation, nausea, diarrhoea and insomnia with duloxetine. Most AEs were mild-to-moderate in intensity. Conclusion: Quetiapine XR monotherapy at 150 and 300mg/day was effective and well tolerated in the treatment of patients with MDD.