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Key considerations for long-term studies with anxiolytics

Published online by Cambridge University Press:  16 April 2020

M Placchi
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Summary

Long-term (minimum six months) safety and efficacy studies with an anti-anxiety agent are aimed at identifying the emergence of any clinical effects not observed during shorter periods of treatment including the identification of late occurring adverse events, loss of therapeutic benefit, or post-treatment withdrawal effects. There is the need to establish diagnostic criteria for persistent anxiety for patients who truly benefit from long-term therapy. Risk factors predisposing to drug dependence should be assessed prior to continuous use. Ideally, long-term continuous studies should be blinded, comparative and placebo-controlled, with an adequate duration of the withdrawal phase. The treatment response of the elderly in comparison to the overall patient sample should be emphasised.

Keywords

anxiolyticsbenzodiazepinesbuspironelong-term treatment
Type
Research Article
Information
European Psychiatry , Volume 11 , Issue 3: Issues of Concern in the Standardization and Harmonization of Psychotropic Drug Trials in Europe , 1996 , pp. 144 - 148
Copyright
Copyright © Elsevier, Paris 1996

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Footnotes

*

The opinions expressed in this paper are those of the author and are not necessarily shared by UCB Pharma.

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