Clinical effectiveness and safety of paroxetine in post-stroke depression: results from a phase 4, open label, multicenter clinical trial with 26 weeks of follow-up

INTRODUCTION: Prevalence of post-stroke depression ranges from 20% to 50%. Treatment of depression positively correlated with the success of rehabilitation, quality of life, and the post-stroke patient's independence. AIM: The primary goal of the study was to establish the therapeutic efficacy of paroxetine (measured by the changes of Hamilton Depression Scale Score) in post-stroke depression. Secondary outcomes were changes in clinical status (based on Clinical Global Impression), alterations of mental capabilities (by Mini-Mental State Examination) and changes in quality of life (based on Quality of Life values). METHOD: An estimation of the efficacy of paroxetine treatment of 788 patients with post-stroke depression (Hamilton Depression Scale Score > 18) was performed in an open-label phase IV multicenter trial, during a clinical (8 weeks) as well as a follow-up period (a total of 26 weeks). The applied doses of paroxetine were: 20, 30 or 40 mg per day, subject to their therapeutic effect. RESULTS: On the third week of the study (i.e.: at the 2nd visit) the mean Hamilton Depression Scale Score decreased significantly to 12.3 points; from a starting mean basic score of 24.8 points. At the conclusion of the clinical phase (by the end of the 8th week) we found an Hamilton Depression Scale Score of 8.6 points, which decreased further to 6.6 points by the end of the follow-up period (i.e.: the 26th week). At the end of the 3rd week 92% of the patients stated that paroxetine was effective while this number grew to 93.1% by the end the 8th week. Events related to secondary outcomes also showed significant improvements of similar size: by the end of the 8th week the clinical status of 92.8% of the patients improved (in 81.3% by a remarkable rate); mental output of the patients (based on Mini-Mental State Examination) grew significantly from a starting score of 26.7 to 27.9 and their Quality of Life values grew from 204 points to 238 points by the end of the 8th week and by the end of the 26th week it reached to 251 points; another indication of a significant improvement of their quality of life. In the course of the study 8.21% of the patients experienced side effects; the most frequent of these were: nausea/vomiting, dizziness, headaches and diarrhea. Serious adverse events occurred in 1.9% of the patients during the 26 weeks period of the study although these were unrelated to the taking of paroxetine. In the course of the study the patients' compliance was clearly good: by the end of the 8th week 94%, at the end of the 26th week 90.7% of them reported for control visitation, in other words, during the 6 months study their dropout rate was less than 10%. CONCLUSION: the selective serotonin-reuptake inhibitor paroxetine effectively improved the symptoms of depression, the functional and cognitive performance, as well as the quality of life of patients with post-stroke depression. The drug was safe and well tolerable.