Abstract
BackgroundMinor and mild-major depression are highly prevalent in primary care. There is insufficient evidence for the effectiveness of antidepressants in the treatment of minor and mild-major depression. We compared the effectiveness of usual primary care treatment, with or without antidepressants, in minor and mild-major depression.MethodsA pragmatic patient-randomized equivalence trial with 52 weeks follow-up was conducted in The Netherlands. In total, 59 primary care physicians (PCPs) recruited and treated 181 adult patients with minor or mild-major depression. Patients were randomized to four consultations within 3 months of usual care plus antidepressants (UCandAD) or usual care alone (UCnoAD). The Montgomery Åsberg Depression Rating Scale (MADRS) was used to assess changes in severity of depressive symptoms. The predefined equivalence margin was set at five points. Multilevel analysis was used to analyze the data. Secondary outcome measures were the Short-Form 36 (SF-36), and the Client Satisfaction Questionnaire (CSQ-8).ResultsPatients received on average 3.0 (SD 1.4) 15-min consultations within 3 months with (n = 85) or without paroxetine (n = 96). Equivalence of UCandAD and UCnoAD was demonstrated in the intention-to-treat analyses as well as the per-protocol analysis after 6 weeks, but not at 13, 26 and 52 weeks follow-up. No statistical differences in effectiveness between treatment groups were found in the intention-to-treat analysis. No differences in the physical and mental functioning (SF-36) were found between the treatment groups. Patients allocated to UCandAD were slightly more satisfied with their treatment at 13 weeks follow-up (but not at 52 weeks follow-up) than patients allocated to UCnoAD. Preliminary analyses suggested that subgroups such as patients with mild-major (instead of a minor) depression might benefit from antidepressant treatment. Patients who were assigned to their preferred treatment (in particular to UCnoAD) were more often compliant and had better clinical outcomes.ConclusionUCandAD was as effective as UCnoAD over the first 6 weeks, but not at 13, 26, and 52 weeks. However, superiority of either treatment could not be demonstrated either. The question whether antidepressants add any clinical effect to usual care remains unresolved. We recommend future studies to look for subgroups of patients who may benefit from antidepressants.Trial registrationDutch Trial Registry ISRCN03007807.
Highlights
Minor and mild-major depression are highly prevalent in primary care
The primary aim of the present study was to examine whether antidepressant medication (UCandAD) adds any clinical effectiveness to non-pharmacological usual care (UCnoAD) by the primary care physician (PCP) in patients with minor or mild-major depression
Because we were interested in the treatment effectiveness in everyday practice, we decided to conduct a pragmatic trial, implying that the interventions were provided by PCPs to typical primary care patients under normal practice circumstances
Summary
Minor and mild-major depression are highly prevalent in primary care. There is insufficient evidence for the effectiveness of antidepressants in the treatment of minor and mildmajor depression. We compared the effectiveness of usual primary care treatment, with or without antidepressants, in minor and mild-major depression. Minor and mild-major depressions are more common than severe major depressive disorders [1]. The estimated point prevalence of minor depression among primary care patients varies between 3.4% and 4.7% [1]. There is insufficient evidence for the effectiveness of antidepressants in the treatment of minor and mild-major depression in primary care [2,3,4,5,6,7]. Specific treatments may not be indicated as there are high rates of improvement with watchful waiting [10]
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