Efficacy, predictors of therapy response, and safety of sertraline in routine clinical practice: Prospective, open-label, non-interventional postmarketing surveillance study in 1878 patients

Department of Psychosomatic and General Internal Medicine, University of Heidelberg, Medical Center, Im Neuenheimer Feld 410, D-69120 Heidelberg, Germany.
Journal of Affective Disorders (Impact Factor: 3.38). 08/2005; 87(2-3):271-9. DOI: 10.1016/j.jad.2005.05.005
Source: PubMed


It is well established that subjects participating in controlled clinical trials may not be representative of patients seen in actual practice. Given that efficacy and safety of sertraline have been investigated almost exclusively in controlled clinical trials, the aim of this study was to investigate efficacy, safety, and predictors of treatment response to sertraline in routine clinical practice.
A total of 1878 depressed outpatients (69.5% female; mean age, 50.3 years) participated in this prospective, open-label, non-interventional, postmarketing surveillance study of sertraline. The primary study outcome was change in depression severity as assessed independently with the Patient Health Questionnaire (PHQ-9) depression scale and Clinical Global Impression (CGI) scales after 12 weeks of treatment. Stepwise logistic regression analyses were used to identify independent predictors of treatment response.
Using standard criteria to define clinical improvement, responder rates were 87.7% (PHQ-9) and 87.2% (CGI), respectively. Remission, i.e. a PHQ-9 score of 5 or below, occurred in 56.9% of patients. Independent baseline predictors of CGI treatment response were: non-chronic course of depression (OR=2.8, p < 0.001), non-psychiatric treatment setting (OR=2.5, p < 0.001), absence of comorbid physical disease (OR=1.9, p < 0.001), depression-related work disability (OR=1.9, p < 0.001), and no previous antidepressant medication (OR=1.5, p=0.03). Adverse events were reported by 4.8% of patients.
Lack of a control group limits the conclusions that can be drawn from this study.
For treatment of depressive disorders in routine outpatient settings, sertraline is safe and efficacious. Patients without prior episodes of depression, without medical comorbidity, and those with higher levels of depression-related functional limitations are most likely to respond to sertraline treatment.

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    • "The PHQ-9 will be used to screen for and monitor the course of depression. The feasibility of the PHQ-9 to evaluate and guide a step-up algorithm has already been proven in outpatients in the primary care setting [40,60] Therefore, in the present study, the PHQ-9 will be used in the same way. The care managers will discuss the effects of the medication and the potential side-effects with the patient, and report to the psychiatrist. "
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