The influence of educational information on depressed outpatients treated with escitalopram: A semi-naturalistic study
Esa V. J. Leinonen, Heikki Niemi
Abstract
Esa V. J. Leinonen, Heikki Niemi
Abstract
This open-label multicentre semi-naturalistic study in Finland assessed the impact of educational information on efficacy of 16-week treatment with escitalopram (5-20 mg/day) in a patient population suffering from depression. Patients were randomized single blind to receive educational information (n=79) or no information (n=78) in addition to open-label escitalopram treatment. Patients were assessed using the Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impression - Severity and - Improvement (CGI-S and CGI-I), Patient Global Evaluation (PGE), and Hopkins Symptom Checklist (SCL-90) scales. Tolerability was assessed by the incidence of adverse events (AEs). A total of 132 (84%) out of 157 patients completed the study, with similar completer rates in both groups. There was no statistically significant effect of educational information on the efficacy of escitalopram treatment, as measured by MADRS, CGI and PGE. Mean MADRS total score was 25.3 at baseline, corresponding to moderate to severe depression, and decreased to 7.9 at the end of the treatment for both groups. The response rate (> or = 50% reduction in MADRS total score from baseline) was 80% at the end of treatment for both groups. The clinical relevance of the improvement was seen in CGI-I and PGE scores and there was a strong correlation between the two scales, indicating agreement by both patients and investigators. AEs were mostly mild and transient and 11 patients (7.0%) dropped out of the study due to AEs, with similar incidence in both groups. Escitalopram was effective and well tolerated in the treatment of depression over a 16-week period in a semi-naturalistic setting, and an additional effect of educational information could not be shown, possibly due to the high response to treatment.
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This open-label multicentre semi-naturalistic study in Finland assessed the impact of educational information on efficacy of 16-week treatment with escitalopram (5-20 mg/day) in a patient population suffering from depression. Patients were randomized single blind to receive educational information (n=79) or no information (n=78) in addition to open-label escitalopram treatment. Patients were assessed using the Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impression - Severity and - Improvement (CGI-S and CGI-I), Patient Global Evaluation (PGE), and Hopkins Symptom Checklist (SCL-90) scales. Tolerability was assessed by the incidence of adverse events (AEs). A total of 132 (84%) out of 157 patients completed the study, with similar completer rates in both groups. There was no statistically significant effect of educational information on the efficacy of escitalopram treatment, as measured by MADRS, CGI and PGE. Mean MADRS total score was 25.3 at baseline, corresponding to moderate to severe depression, and decreased to 7.9 at the end of the treatment for both groups. The response rate (> or = 50% reduction in MADRS total score from baseline) was 80% at the end of treatment for both groups. The clinical relevance of the improvement was seen in CGI-I and PGE scores and there was a strong correlation between the two scales, indicating agreement by both patients and investigators. AEs were mostly mild and transient and 11 patients (7.0%) dropped out of the study due to AEs, with similar incidence in both groups. Escitalopram was effective and well tolerated in the treatment of depression over a 16-week period in a semi-naturalistic setting, and an additional effect of educational information could not be shown, possibly due to the high response to treatment.
Key concepts: Escitalopram, Clinical Global Impression, Tolerability, Rating scale, Depression (economics), Adverse effect, Internal medicine, Population