Escitalopram for comorbid depression and anxiety in elderly patients: A 12-week, open-label, flexible-dose, pilot trial

Abstract

Background: Comorbid depression and anxiety may result in greater symptom severity and poorer treatment response than either condition alone. Selective serotonin reuptake inhibitors have been found to be effective in treating both depression and anxiety; however, pharmacodynamic and pharmacokinetic changes associated with aging warrant special attention in medication trials in older patients. Objective: The objective of this study was to assess the efficacy and tolerability of short-term (12-week) administration of escitalopram oxalate 10 to 20 mg/d for moderate to marked comorbid depression and anxiety in elderly patients. Methods: This open-label, flexible-dose (10–20 mg/d), pilot trial was conducted at the Psychiatry Service, Veterans Affairs Medical Center, Cincinnati, Ohio. Outpatients aged ≥65 years were included if they met the criteria for comorbid major depressive disorder (MDD) and generalized anxiety disorder (GAD), as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, for ≥4 weeks and had a baseline Montgomery-sberg Depression Rating Scale (MADRS) score of >22 and a Hamilton Rating Scale for Anxiety (HAM-A) score of ≥18. All patients received escitalopram 10 to 20 mg/d. The primary efficacy variables were the mean changes from baseline in total MADRS and HAM-A scores at 12 weeks (last observation carried forward). The secondary efficacy end point was the change from baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) 8 subscale scores. Adverse events were assessed at each visit (treatment weeks 1, 2, 3, 4, 6, 8, 10, and 12) with the use of open-ended questioning. Results: Twenty patients were enrolled (mean [SD] age, 73.0 [4.8] years; 6 [30%] women; race: 17 [85%] white, 2 [10%] black, and 1 [5%] “other”). Seventeen (85%) of 20 patients completed the study; 3 (15%) withdrew: 1 (5%) due to lack of efficacy and 2 (10%) due to adverse events (dizziness and somnolence [1 (5%) patient each]). Statistically significant improvements from baseline to end point were found with escitalopram treatment (MADRS: t 19 = 7.38, P < 0.001, effect size = 2.93; HAM-A: t 19 = 4.19, P < 0.001, effect size = 1.83). Significant changes from baseline in scores on 4 (Social Functioning, Role Functioning-Emotional, Mental Health, and Energy/Fatigue) of the 8 subscales of the SF-36 were als of ound (all, P < 0.01). Conclusion: In this small study in elderly patients with comorbid MDD and GAD, treatment with escitalopram 10 to 20 mg/d for 12 weeks was associated with significant improvements in symptoms of depression and anxiety.