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National Depressive and Manic-Depressive Association Consensus Statement on the Use of Placebo in Clinical Trials of Mood Disorders
Dennis S. Charney, MD;
Charles B. Nemeroff, MD, PhD;
Lydia Lewis;
Sally K. Laden, MS;
Jack M. Gorman, MD;
Eugene M. Laska, PhD;
Michael Borenstein, PhD;
Charles L. Bowden, MD;
Arthur Caplan, PhD;
Graham J. Emslie, MD;
Dwight L. Evans, MD;
Barbara Geller, MD;
Lenore E. Grabowski;
Jay Herson, PhD;
Ned H. Kalin, MD;
Paul E. Keck, Jr, MD;
Irving Kirsch, PhD;
K. Ranga R. Krishnan, MD;
David J. Kupfer, MD;
Robert W. Makuch, PhD;
Franklin G. Miller, PhD;
Herbert Pardes, MD;
Robert Post, MD;
Mildred M. Reynolds, EdD, MSW;
Laura Roberts, MD;
Jerrold F. Rosenbaum, MD;
Donald L. Rosenstein, MD;
David R. Rubinow, MD;
A. John Rush, MD;
Neal D. Ryan, MD;
Gary S. Sachs, MD;
Alan F. Schatzberg, MD;
Susan Solomon, JD;
for the Consensus Development Panel
Arch Gen Psychiatry. 2002;59:262-270.
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.
From the National Institute of Mental Health, Bethesda, Md (Drs Charney,
Miller, Post, Rosenstein, and Rubinow); Department of Psychiatry and Behavioral
Sciences, Emory University School of Medicine, Atlanta, Ga (Dr Nemeroff);
National Depressive and Manic-Depressive Association, Chicago, Ill (Mss Lewis
and Grabowski and Dr Reynolds); Scientific Therapeutics Information, Inc,
Springfield, NJ (Ms Laden); Department of Psychiatry, Columbia University
College of Physicians and Surgeons, New York, NY (Dr Gorman); Nathan S. Kline
Institute for Psychiatric Research, Orangeburg, NY (Dr Laska); Department
of Psychiatry, Albert Einstein College of Medicine, New York (Dr Borenstein);
Department of Psychiatry, University of Texas Health Sciences Center at San
Antonio (Dr Bowden); Division of Bioethics (Dr Caplan) and Department of Psychiatry
(Dr Evans), University of Pennsylvania, Philadelphia; Department of Psychiatry,
University of Texas Southwestern Medical Center, Dallas (Drs Emslie and Rush);
Department of Psychiatry, Washington University at St Louis, St Louis, Mo
(Dr Geller); Applied Logic Associates, Inc, Houston, Tex (Dr Herson); Department
of Psychiatry, University of Wisconsin Medical School, Madison (Dr Kalin);
Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati,
Ohio (Dr Keck); Department of Psychology, University of Connecticut, Storrs
(Dr Kirsch); Duke University Medical Center, Durham, NC (Dr Krishnan); University
of Pittsburgh Medical School, Pittsburgh, Pa (Drs Kupfer and Ryan); Yale University
School of Medicine, New Haven, Conn (Dr Makuch); Department of Psychiatry,
New York–Presbyterian Hospital, New York (Dr Pardes); Department of
Psychiatry, University of New Mexico, Albuquerque (Dr Roberts); Department
of Psychiatry, Harvard Medical School, Boston, Mass (Drs Rosenbaum and Sachs);
Department of Psychiatry and Behavioral Sciences, Stanford University School
of Medicine, Stanford, Calif (Dr Schatzberg); and The Child and Adolescent
Bipolar Foundation, Palo Alto, Calif (Ms Solomon).
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