National depressive and manic-depressive association consensus statement on the use of placebo in clinical trials of mood disorders

Dennis S. Charney, Charles B. Nemeroff, Lydia Lewis, Sally K. Laden, Jack M. Gorman, Eugene M. Laska, Michael Borenstein, Charles L. Bowden, Arthur Caplan, Graham J. Emslie, Dwight L. Evans, Barbara Geller, Lenore E. Grabowski, Jay Herson, Ned H. Kalin, Paul E. Keck, Irving Kirsch, K. Ranga R. Krishnan, David J. Kupfer, Robert W. MakuchFranklin G. Miller, Herbert Pardes, Robert Post, Mildred M. Reynolds, Laura Roberts, Jerrold F. Rosenbaum, Donald L. Rosenstein, David R. Rubinow, A. John Rush, Neal D. Ryan, Gary S. Sachs, Alan F. Schatzberg, Susan Solomon

Research output: Contribution to journalReview articlepeer-review

94 Scopus citations

Abstract

A consensus conference on the use of placebo in mood disorder studies consisted of expert presentations on bioethics, biostatistics, unipolar depression, and bipolar disorder. Work groups considered evidence and presented statements to the group. Although it was not possible to write a document for which there was complete agreement on all issues, the final document incorporated input from all authors. There was consensus that placebo has a definite role in mood disorder studies. Findings of equivalence between a new drug and standard treatment in active control studies is not evidence of efficacy unless the new drug is also significantly more effective than placebo. Add-on studies in which patients are randomized to standard therapy plus the investigational drug or standard therapy plus placebo are especially indicated for high-risk patients. Mood disorders in elderly and pediatric patients are understudied, and properly designed trials are urgently needed. Research is needed on the ethical conduct of studies to limit risks of medication-free intervals and facilitate poststudy treatment. Patients must fully understand the risks and lack of individualized treatment involved in research.

Original languageEnglish (US)
Pages (from-to)262-270
Number of pages9
JournalArchives of General Psychiatry
Volume59
Issue number3
DOIs
StatePublished - Jan 1 2002

ASJC Scopus subject areas

  • Arts and Humanities (miscellaneous)
  • Psychiatry and Mental health

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