National Depressive and Manic-Depressive Association consensus statement on the use of placebo in clinical trials of mood disorders.
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.
Charney
Dennis S
DS
Division of Intramural Research Programs, National Institute of Mental Health, 9000 Rockville Pike, Bethesda, MD 20892, USA. charneyd@nih.gov
Nemeroff
Charles B
CB
Lewis
Lydia
L
Laden
Sally K
SK
Gorman
Jack M
JM
Laska
Eugene M
EM
Borenstein
Michael
M
Bowden
Charles L
CL
Caplan
Arthur
A
Emslie
Graham J
GJ
Evans
Dwight L
DL
Geller
Barbara
B
Grabowski
Lenore E
LE
Herson
Jay
J
Kalin
Ned H
NH
Keck
Paul E
PE
Kirsch
Irving
I
Krishnan
K Ranga R
KR
Kupfer
David J
DJ
Makuch
Robert W
RW
Miller
Franklin G
FG
Pardes
Herbert
H
Post
Robert
R
Reynolds
Mildred M
MM
Roberts
Laura
L
Rosenbaum
Jerrold F
JF
Rosenstein
Donald L
DL
Rubinow
David R
DR
Rush
A John
AJ
Ryan
Neal D
ND
Sachs
Gary S
GS
Schatzberg
Alan F
AF
Solomon
Susan
S
D001714:Bipolar Disorder / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003866:Depressive Disorder / Q000188:drug therapy*; D004989:Ethics; D006801:Humans; D015990:Placebo Effect; D010919:Placebos / Q000627:therapeutic use*; D016896:Treatment Outcome
D010919:Placebos