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The scientific and ethical basis for placebo-controlled trials in depression and schizophrenia: an FDA perspective

Published online by Cambridge University Press:  16 April 2020

T.P. Laughren
T.P. Laughren*
Affiliation:
Psychiatric Drug Products Group, Division of Neuropharmacological Drug Products (HFD-120), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA
*
*Correspondence and reprints. E-mail address: [email protected] (T.P. Laughren).
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Summary

There is a tension between the need for scientifically valid trials of new psychotropic drugs and concern about conducting placebo-controlled trials, the trials psychopharmacologists consider the gold standard trial, when this requires that some patients be denied existing effective therapy. This paper will review the scientific principles supporting the need for placebo-controlled trials in depression and schizophrenia, and will provide preliminary data on failure rates of placebo-controlled trials for these disorders, as illustrations of the application of these principles. Next, the ethical issues pertinent to the conduct of placebo-controlled trials for these two serious psychiatric disorders will be reviewed. Preliminary data on suicides in placebo-controlled depression and schizophrenia trials will be presented to argue for the ethical acceptability of the conduct of placebo-controlled trials in these two conditions.

Keywords

depressionethicsplacebopsychopharmacologyschizophrenia
Type
Original Articles
Information
European Psychiatry , Volume 16 , Issue 7 , November 2001 , pp. 418 - 423
Copyright
Copyright © European Psychiatric Association 2001

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Footnotes

1

Dr. Laughren is with the Food and Drug Administration, Rockville, MD. However, Dr. Laughren’s contribution to this chapter was made in his private capacity. No official support or endorsement by the Food and Drug Administration is intended or should be inferred.

References

Beasley, CMDornseif, BEBosomworth, JCSayler, MERampey, AH.Fluoxetine and suicide: a meta-analysis of controlled trials of treatment for depression. BMJ 1991; 303: 685–92.CrossRefGoogle ScholarPubMed
Ellenberg, SSTemple, R.Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: practical issues and specific cases. Ann Intern M 2000; 133: 464–70.Google ScholarPubMed
Food and Drug Administration. Federal Food, Drug, and Cosmetic Act, As Amended, FDA 93-1051. Washington, DC: Superintendent of Documents, US Government Printing Office; 1993.Google Scholar
Food and Drug Administration. International Conference on Harmonization: choice of control group in clinical trials. Federal Register. 1999; 64: 51767–80.Google Scholar
Food and Drug Administration. Adequate and well-controlled trials. Code of Federal Regulations (Revised as of April 1, 2001), Title 21, Part 314.126. Washington, DC: US Government Printing Office; 2001.Google Scholar
Khan, AFWarner, HABrown, WA.Symptom reduction and suicide risk in patients treated with placebo in antidepressant trials. Arch Gen Psychiatry 2000; 57: 311–7.CrossRefGoogle Scholar
Rothman, KJMichels, KB.The continued unethical use of placebo controls. N Engl J M 1994; 331: 394–8.CrossRefGoogle Scholar
Temple, REllenberg, SS.Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues. Ann Intern M 2000; 133: 455–63.Google ScholarPubMed
Weijer, C.Placebo-controlled trials in schizophrenia: are they ethical? Are they necessary?. Schizophr Res 1999; 35: 211–8.CrossRefGoogle ScholarPubMed
Woods, SWStolar, MSernyak, MJCharney, DS.Consistency of atypical antipsychotic superiority to placebo in recent clinical trials. Biol Psychiatry 2001; 49: 64–70.CrossRefGoogle ScholarPubMed
World Medical Association Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. October, 2000. www.wma.net.Google Scholar
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