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BACKGROUND Recent publications have raised questions over the efficacy and clinically relevant effects of antidepressants that have been approved for the treatment of major depression. In this context, the European Commission requested that the European Medicines Agency (EMEA) and its scientific committee (CHMP) issue an opinion on these data under Article(More)
Placebo-controlled trials are used widely in the development of new pharmacological treatments. They have sometimes been challenged as being unethical, in clinical situations where patients can receive an existing effective and acceptable treatment. It has been argued that studies of potential antidepressants should employ only a comparator-controlled(More)
Proof of efficacy of a psychotropic medicinal product is the key point of clinical psychopharmacology. This especially concerns the licensing of a new compound, but apart from this special case, lots of efficacy questions need to be answered in clinical psychopharmacology, such as, e.g. the question of the efficacy of a combination therapy. The methodology(More)
OBJECTIVE To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009. PARTICIPANTS This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as(More)
OBJECTIVE To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009. PARTICIPANTS This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as(More)
This conceptual review summarises the results of relevant studies on antidepressants, mood stabilisers such as lithium and anticonvulsants, and second generation antipsychotics in the indication of bipolar depression. Based on methodological and clinical considerations, the position of antidepressants and the possible alternatives in this indication are(More)
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