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 language | English |
|---|---|
| Pages (from-to) | 262-270 |
| Number of pages | 9 |
| Journal | Archives of General Psychiatry |
| Volume | 59 |
| Issue number | 3 |
| State | Published - Mar 20 2002 |
| Externally published | Yes |
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ASJC Scopus subject areas
- Psychiatry and Mental health
Cite this
National depressive and manic-depressive association consensus statement on the use of placebo in clinical trials of mood disorders. / Charney, Dennis S.; Nemeroff, Charles; Lewis, Lydia; Laden, Sally K.; Gorman, Jack M.; Laska, Eugene M.; Borenstein, Michael; Bowden, Charles L.; Caplan, Arthur; Emslie, Graham J.; Evans, Dwight L.; Geller, Barbara; Grabowski, Lenore E.; Herson, Jay; Kalin, Ned H.; Keck, Paul E.; Kirsch, Irving; Krishnan, K. Ranga R; Kupfer, David J.; Makuch, Robert W.; Miller, Franklin G.; Pardes, Herbert; Post, Robert; Reynolds, Mildred M.; Roberts, Laura; Rosenbaum, Jerrold F.; Rosenstein, Donald L.; Rubinow, David R.; John Rush, A.; Ryan, Neal D.; Sachs, Gary S.; Schatzberg, Alan F.; Solomon, Susan.
In: Archives of General Psychiatry, Vol. 59, No. 3, 20.03.2002, p. 262-270.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - National depressive and manic-depressive association consensus statement on the use of placebo in clinical trials of mood disorders
AU - Charney, Dennis S.
AU - Nemeroff, Charles
AU - Lewis, Lydia
AU - Laden, Sally K.
AU - Gorman, Jack M.
AU - Laska, Eugene M.
AU - Borenstein, Michael
AU - Bowden, Charles L.
AU - Caplan, Arthur
AU - Emslie, Graham J.
AU - Evans, Dwight L.
AU - Geller, Barbara
AU - Grabowski, Lenore E.
AU - Herson, Jay
AU - Kalin, Ned H.
AU - Keck, Paul E.
AU - Kirsch, Irving
AU - Krishnan, K. Ranga R
AU - Kupfer, David J.
AU - Makuch, Robert W.
AU - Miller, Franklin G.
AU - Pardes, Herbert
AU - Post, Robert
AU - Reynolds, Mildred M.
AU - Roberts, Laura
AU - Rosenbaum, Jerrold F.
AU - Rosenstein, Donald L.
AU - Rubinow, David R.
AU - John Rush, A.
AU - Ryan, Neal D.
AU - Sachs, Gary S.
AU - Schatzberg, Alan F.
AU - Solomon, Susan
PY - 2002/3/20
Y1 - 2002/3/20
N2 - 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.
AB - 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.
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UR - http://www.scopus.com/inward/citedby.url?scp=0036195182&partnerID=8YFLogxK
M3 - Article
C2 - 11879164
AN - SCOPUS:0036195182
VL - 59
SP - 262
EP - 270
JO - JAMA Psychiatry
JF - JAMA Psychiatry
SN - 2168-622X
IS - 3
ER -