National Depressive and Manic-Depressive Association consensus statement on the use of placebo in clinical trials of mood disorders.

Published

Journal Article (Review)

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.

Full Text

Duke Authors

Cited Authors

  • Charney, DS; Nemeroff, CB; Lewis, L; Laden, SK; Gorman, JM; Laska, EM; Borenstein, M; Bowden, CL; Caplan, A; Emslie, GJ; Evans, DL; Geller, B; Grabowski, LE; Herson, J; Kalin, NH; Keck, PE; Kirsch, I; Krishnan, KRR; Kupfer, DJ; Makuch, RW; Miller, FG; Pardes, H; Post, R; Reynolds, MM; Roberts, L; Rosenbaum, JF; Rosenstein, DL; Rubinow, DR; Rush, AJ; Ryan, ND; Sachs, GS; Schatzberg, AF; Solomon, S; Consensus Development Panel,

Published Date

  • March 2002

Published In

Volume / Issue

  • 59 / 3

Start / End Page

  • 262 - 270

PubMed ID

  • 11879164

Pubmed Central ID

  • 11879164

International Standard Serial Number (ISSN)

  • 0003-990X

Digital Object Identifier (DOI)

  • 10.1001/archpsyc.59.3.262

Language

  • eng

Conference Location

  • United States