title: National Depressive and Manic-Depressive Association consensus statement on the use of placebo in clinical trials of mood disorders.
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.
authors.affiliation: Division of Intramural Research Programs, National Institute of Mental Health, 9000 Rockville Pike, Bethesda, MD 20892, USA. charneyd@nih.gov
authors.forename: Dennis S
authors.initials: DS
authors.lastname: Charney
authors.forename: Charles B
authors.initials: CB
authors.lastname: Nemeroff
authors.forename: Lydia
authors.initials: L
authors.lastname: Lewis
authors.forename: Sally K
authors.initials: SK
authors.lastname: Laden
authors.forename: Jack M
authors.initials: JM
authors.lastname: Gorman
authors.forename: Eugene M
authors.initials: EM
authors.lastname: Laska
authors.forename: Michael
authors.initials: M
authors.lastname: Borenstein
authors.forename: Charles L
authors.initials: CL
authors.lastname: Bowden
authors.forename: Arthur
authors.initials: A
authors.lastname: Caplan
authors.forename: Graham J
authors.initials: GJ
authors.lastname: Emslie
authors.forename: Dwight L
authors.initials: DL
authors.lastname: Evans
authors.forename: Barbara
authors.initials: B
authors.lastname: Geller
authors.forename: Lenore E
authors.initials: LE
authors.lastname: Grabowski
authors.forename: Jay
authors.initials: J
authors.lastname: Herson
authors.forename: Ned H
authors.initials: NH
authors.lastname: Kalin
authors.forename: Paul E
authors.initials: PE
authors.lastname: Keck
authors.forename: Irving
authors.initials: I
authors.lastname: Kirsch
authors.forename: K Ranga R
authors.initials: KR
authors.lastname: Krishnan
authors.forename: David J
authors.initials: DJ
authors.lastname: Kupfer
authors.forename: Robert W
authors.initials: RW
authors.lastname: Makuch
authors.forename: Franklin G
authors.initials: FG
authors.lastname: Miller
authors.forename: Herbert
authors.initials: H
authors.lastname: Pardes
authors.forename: Robert
authors.initials: R
authors.lastname: Post
authors.forename: Mildred M
authors.initials: MM
authors.lastname: Reynolds
authors.forename: Laura
authors.initials: L
authors.lastname: Roberts
authors.forename: Jerrold F
authors.initials: JF
authors.lastname: Rosenbaum
authors.forename: Donald L
authors.initials: DL
authors.lastname: Rosenstein
authors.forename: David R
authors.initials: DR
authors.lastname: Rubinow
authors.forename: A John
authors.initials: AJ
authors.lastname: Rush
authors.forename: Neal D
authors.initials: ND
authors.lastname: Ryan
authors.forename: Gary S
authors.initials: GS
authors.lastname: Sachs
authors.forename: Alan F
authors.initials: AF
authors.lastname: Schatzberg
authors.forename: Susan
authors.initials: S
authors.lastname: Solomon
mesh_terms: 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
chemical_list: D010919:Placebos