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February 1996

Clinical Evaluation of Psychotropic Drugs: Principles and Guidelines

Author Affiliations

Rochester, NY

Arch Neurol. 1996;53(2):119. doi:10.1001/archneur.1996.00550020021006

This article is only available in the PDF format. Download the PDF to view the article, as well as its associated figures and tables.


This text is a source book in clinical trials of psychotropic drugs that incorporates the experience of a wide group of experts. A joint American College of Neuropsychopharmacology and National Institute of Mental Health task force was established to develop this extremely thorough work. The natural flow of chapters, despite numerous authors, reflects the careful planning in creating this book. There are numerous recent references, and the index is easy to use.

The text opens with an interesting section on historical perspectives and becomes gradually more specific. Section II walks the reader logically through general principles in the evaluation of psychotropic drugs. This comprehensive and well-organized section begins with design issues; continues on to patient selection, assessment of clinical change, pharmacologic considerations, statistical issues, clinical trial implementation, premarketing safety, postmarketing surveillance, and documenting and reporting study results; and concludes with an important chapter on ethical and legal considerations. Although references

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