Background and hypothesis: Post-stroke emotional symptoms are common and adversely influence the patients’ outcome. We aim to evaluate the efficacy of escitalopram in patients with acute stroke for the prevention of various emotional disorders, and for improvement of neurologic, cognitive function and patient quality of life.
Method: In this multicenter, placebo-controlled, double-blind trial, 405 stroke patients (within 21 days after onset) were randomized either to the escitalopram (n = 217) (5 mg -10mg) or placebo (n = 188) for 3 months. Depressive symptoms (Montgomery-Asberg Depression Rating Scale [MADRS] and mini-international neuropsychiatric interview [MINI]), emotional incontinence (Kim’s criteria), anger proneness (Modified Spielberger trait), cognition (MOCA test), Modified Rankin scale (MRS), and quality of life (Stroke Specific QOL) were assessed initially, and at 3 and 6-months.
Results: Baseline characteristics were similar between the groups. Proportions of patients with MADRS≥16, the primary outcome, were not different at 3-month (placebo vs. escitalopram group, 13.8% vs. 12.0%, p=0.579). However, new development of depression determined by MINI was lower in the escitalopram group (0 vs. 4 patients, P = 0.046). For the secondary outcomes, anger proneness score was lower in the escitalopram group (21.5 vs 20.1 at 3-month, P = 0.011). There were no significant differences in other items at 3-months: emotional incontinence (% of patients, 8.5% vs. 10.2%, p=0.565), MOCA score (21.1±6.8 vs. 20.9±7.2, p=0.704), MRS (3.1±1.2 vs. 3.0±1.3, p=0.822), and patient quality of life (165.0±38.8 vs. 166.7±39.1, p=0.667). When chronological changes of MADRS were analyzed after categorizing patients into normal (0-6), mild (7-15), and moderate/severe (≥16) depression groups, escitalopram significantly improved MADRS of patients with mild depression (10.30 to 7.23 vs. 10.91 to 5.06, p = 0.036).
Conclusion: Escitalopram was not effective in the prevention of post-stroke depressive symptoms, and did not improve cognitive function, neurologic severity, and patient quality of life. However, it prevented development of depression defined by MINI, anger-proneness and seems to improve depressive symptoms in patients with mild depression.