Purpose This article provides working definitions and a conceptual framework to understand the roles of biomarkers in clinical research. Recent findings The definitions of the terms discussed in this article—medical signs, symptoms, biomarkers, surrogate endpoints, clinical endpoints, validation—are still under discussion, as are their relationships to each other, but broad consensus has developed in the past decade and a half about the necessity of distinguishing between, in particular, surrogate and clinical endpoints. Summary This article outlines the major definitions of the key terms in this field and considers select cases where misunderstandings about the terms led to flawed research conclusions.
Delusional misidentification syndromes and erotomania are rare entities, each with several distinct manifestations and no clearly defined treatment regimen. Here we expand upon an earlier literature review and describe the case of a 40-year-old woman with a history of bipolar I disorder who presented after an extended period of medication nonadherence with symptoms consistent with both of these conditions; she believed that the staff on the unit were in fact disguised celebrities and fictional characters, and she claimed to be married to a famous singer. The exact relationship of these symptoms (and indeed, even their basic etiologies) remains unclear; however, both delusional syndromes resolved with a combination of risperidone and lithium therapy. Although earlier literature has suggested pimozide as the most effective agent for treating delusional syndromes, given the more favorable side-effect profile of atypical versus typical antipsychotics, this case suggests a role for risperidone as a first-line treatment in such situations.
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