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The place of placebo? The ethics of placebo-controlled trials in bipolar disorder

  • Michael Berk (a1) (a2) (a3)
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Copyright

Corresponding author

Michael Berk, Department Clinical and Biomedical Sciences, Swanston Centre — Barwon Health, University of Melbourne, PO Box 281, Geelong, Victoria 3220, Australia Tel: +61 3 5226 7450; Fax: +61 3 5246 5165; E-mail: mikebe@barwonhealth.org.au

References

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3.Mudur, G. Indian study sparks debate on the use of placebo in psychiatry trials. BMJ 2006;332:566.
4.Kim, SY. Benefits and burdens of placebos in psychiatric research. Psychopharmacology (Berl) 2003;171:1318.
5.Carpenter, WT Jr, Schooler, NR, Kane, JM. The rationale and ethics of medication-free research in schizophrenia. Arch Gen Psychiatry 1997;54:401407.
6.Kamlet, MS, Paul, N, Greenhouse, Jet al. Cost utility analysis of maintenance treatment for recurrent depression. Control Clin Trials 1995;16:1740.
7.Murray, CJ, Lopez, AD. Alternative projections of mortality and disability by cause 1990–2020: Global Burden of Disease Study. Lancet 1997;349:14981504.
8.Bowden, CL, Calabrese, Jr, Mcelroy, SLet al. A randomized, placebo-controlled 12-month trial of divalproex and lithium in treatment of outpatients with bipolar I disorder. Divalproex Maintenance Study Group. Arch Gen Psychiatry 2000;57:481489.
9.Laughren, TP. The scientific and ethical basis for placebo-controlled trials in depression and schizophrenia: an FDA perspective. Eur Psychiatry 2001;16:418423.
10.Walsh, BT, Seidman, SN, Sysko, R, Gould, M. Placebo response in studies of major depression: variable, substantial, and growing. JAMA 2002;287:18401847.
11.Lakoff, A. The mousetrap: managing the placebo effect in antidepressant trials. Mol Interv 2002;2:7276.
12.Johnson, RE, McFarland, BH. Lithium use and discontinuation in a health maintenance organization. Am J Psychiatry 1996;153:9931000.
13.Baldessarini, RJ, Leahy, L, Arcona, Set al. Patterns of psychotropic drug prescription for U.S. patients with diagnoses of bipolar disorders. Psychiatr Serv 2007;58:8591.

The place of placebo? The ethics of placebo-controlled trials in bipolar disorder

  • Michael Berk (a1) (a2) (a3)

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