Abstract
BackgroundInappropriate use of antidepressants (AD), defined as either continuation in the absence of a proper indication or continuation despite the lack of therapeutic efficacy, applies to approximately half of all long term AD users.Methods/designWe have designed a cluster randomized controlled clinical trial to assess the (cost-) effectiveness of an antidepressant cessation advice in the absence of a proper indication for maintenance treatment with antidepressants in primary care.We will select all patients using antidepressants for over 9 months from 45 general practices. Patients will be diagnosed using the Composite International Diagnostic Interview (CIDI) version 3.0, extended with questions about the psychiatric history and previous treatment strategies. General practices will be randomized to either the intervention or the control group. In case of overtreatment, defined as the absence of a proper indication according to current guidelines, a cessation advice is given to the general practitioner. In the control groups no specific information is given. The primary outcome measure will be the proportion of patients that successfully discontinue their antidepressants at one-year follow-up. Secondary outcomes are dimensional measures of psychopathology and costs.DiscussionThis study protocol provides a detailed overview of the design of the trial. Study results will be of importance for refining current guidelines. If the intervention is effective it can be used in managed care programs.Trial registrationNTR2032
Highlights
Inappropriate use of antidepressants (AD), defined as either continuation in the absence of a proper indication or continuation despite the lack of therapeutic efficacy, applies to approximately half of all long term AD users
The Dutch NEMESIS data show that half of the identified antidepressant drug users still suffered from a depressive or anxiety disorder [5] and are in need of subsequent treatment steps we considered this type of inappropriate treatment beyond the scope of the study reported here
We have described the study protocol of a clusterrandomised controlled clinical trial to evaluate the impact of cessation advice to the general practitioner (GP) in order to reduce overtreatment with antidepressants in general practice
Summary
We have described the study protocol of a clusterrandomised controlled clinical trial to evaluate the impact of cessation advice to the GP in order to reduce overtreatment with antidepressants in general practice. Available data suggested comparable proportions of patients being over- or undertreated, reality was hardhearted Recruitment rates in both trials were a little disappointing, but for the trial described in this paper we could include sufficient patients to achieve over 85% power based on a priori effect-sizes by recruiting more general practitioners to participate in our project. The reliability of the treatment proposals was excellent, as shown by a 100% agreement between the results of the second psychiatricGP couple on 10 randomly chosen patients Clinical relevance of this trial (for update of guidelines) This study aimed to answer questions on the (cost) effectiveness to taper antidepressant use in patients who have no recent diagnosis of depression and/or anxiety.
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