Efficacy, predictors of therapy response, and safety of sertraline in routine clinical practice: prospective, open-label, non-interventional postmarketing surveillance study in 1878 patients.
ABSTRACT 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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ABSTRACT: Depression, anxiety, and somatization are the most frequently observed mental disorders in primary health care. Our main objective was to draw on the often neglected general practitioners' (GPs) perspective to investigate what characterizes these three common mental diagnoses with regard to creating more suitable categories in the DSM-V and ICD-11. We collected independent data from 1751 primary care patients (participation rate=77%) and their 32 treating GPs in Germany. Patients filled out validated patient self-report measures for depression (PHQ-9), somatic symptom severity (PHQ-15), and illness anxiety (Whiteley-7), and questions regarding coping and attribution of illness. GPs' clinical diagnoses and associated features were assessed. Patients diagnosed by their GPs with depression, anxiety, and/or somatoform disorders were significantly older, less educated, and more often female than the reference group not diagnosed with a mental disorder. They had visited the GP more often, had a longer duration of symptoms, and were more often under social or financial stress. Among the mental disorders diagnosed by the GPs, depression (OR=4.4; 95% CI=2.6 to 7.5) and comorbidity of somatoform, depressive, and anxiety disorders (OR=9.5; 95% CI=4.6 to 19.4) were associated with the largest degrees of impairment compared to the reference group. Patients diagnosed as having a somatoform/functional disorder only had mildly elevated impairment on all dimensions (OR=2.0; 95% CI=1.4 to 2.7). Similar results were found for the physicians' attribution of psychosocial factors for cause and maintenance of the disease, difficult patient-doctor relationship, and self-assessed mental disorder. In order to make the DSM-V and ICD-11 more suitable for primary care, we propose providing appropriate diagnostic categories for (1) the many mild forms of mental syndromes typically seen in primary care; and (2) the severe forms of comorbidity between somatoform, depressive, and/or anxiety disorder, e.g., with a dimensional approach.Journal of psychosomatic research 10/2009; 67(3):189-97. DOI:10.1016/j.jpsychores.2009.04.013 · 2.84 Impact Factor
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ABSTRACT: The frequent co-occurrence of depression and somatic symptoms poses a continuing challenge to clinicians, researchers and experts involved in drawing up classifications. In this review we present recently published literature on aspects of epidemiology, classification and treatment in this important overlap area. From the multitude of papers published annually on the co-occurrence of different pain conditions and depression, temporomandibular dysfunction stands out this year by sheer quantity; it can be seen as a model case of the necessity for differentiated high-quality assessments on the biological as well as the psychosocial level. There is a general move to separate utility of diagnostic classifications from their validity, and this strengthens classificatory approaches that help to view the regular overlap of depression, pain and other somatic symptoms as the rule rather than the exception. The incorporation of cognitive variables like causal attributions should help to distinguish clinically relevant subtypes among overlap cases. The classificatory future of the category of 'somatoform disorders' is somewhat in doubt, but reforms seem to be more productive than abolishment. Psychopharmacology provides rather intense recent coverage of the overlap field, with newer dual serotonergic-noradrenergic reuptake inhibitors offering some promise. Treating the overlap of depression, pain and other somatic symptoms as the rule rather than the exception is necessary for adequate aetiological research as well as for diagnosis and treatment, with one-dimensional classificatory and treatment approaches almost certainly being insufficient.Current Opinion in Psychiatry 02/2006; 19(1):19-24. DOI:10.1097/01.yco.0000189880.11059.8d · 3.55 Impact Factor