Placebo-controlled studies in schizophrenia - Ethical and scientific perspectives: An overview of conference proceedings

Schizophrenia Research

Volumn 35, Issue 3, 1999, Pages 189-200

  Zipursky, Robert B ^a   Darby, Padraig ^a  

^a UNIVERSITY OF TORONTO   (Canada)

Author keywords

Clinical trials; Ethics; Informed consent; Placebo; Schizophrenia

Indexed keywords

CLINICAL RESEARCH; CONFERENCE PAPER; DRUG RESEARCH; HUMAN; MEDICAL ETHICS; PRIORITY JOURNAL; PSYCHOPHARMACOTHERAPY; SCHIZOPHRENIA; TREATMENT PLANNING;

BIOMEDICAL AND BEHAVIORAL RESEARCH; MENTAL HEALTH THERAPIES;

ANTIPSYCHOTIC AGENTS; CLINICAL TRIALS; ETHICS, MEDICAL; EVIDENCE-BASED MEDICINE; HUMANS; INFORMED CONSENT; PATIENT COMPLIANCE; RECURRENCE; RESEARCH; SCHIZOPHRENIA;

EID: 0033558064     PISSN: 09209964     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0920-9964(98)00124-8     Document Type: Conference Paper

References (16)

1. Applebaum P.S. Drug-free research in schizophrenia: an overview of the controversy. IRB. 18:1996;1-5.
2. Beasley C.M. Jr., Tollefson G., Tran P.et al. Olanzapine versus placebo and haloperidol: acute phase results of the North American Double-Blind olanzapin trial. Neuropsychopharmacology. 14:1996;111-123.
3. Carpenter W.J. Jr., Schooler N.R., Kane J.M. The rationale and ethics of medication-free research in schizophrenia. Arch. Gen. Psychiatry. 54:1997;401-407.
4. Curson D.A., Hirsch S.R., Platt S.D., Bamber R.W., Barnes T.R.E. Does short term placebo treatment of chronic schizophrenia produce long term harm? Br. Med. J. 293:1986;726-728.
5. Fins J.J., Miller F.G. The call of the sirens: navigating the ethics of medication-free research in schizophrenia. Arch. Gen. Psychiatry. 54:1997;415-416.
6. Henn F.A., Lader M. Medication-free research with schizophrenic patients: A European perspective. Arch. Gen. Psychiatry. 54:1997;412-413.
7. Kane J., Honigfeld G., Singer J., Meltzer H. Clozapine for the treatment-resistant schizophrenic: a double-blind comparison with chlorpromazine. Arch. Gen. Psychiatry. 45:1988;789-796.
8. Lasagna L. The Helsinki Declaration: Timeless guide or irrelevant anachronism. J. Clin. Psychopharmacol. 15:1995;96-98.
9. Marder S.R., Meibach R.C. Risperidone in the treatment of schizophrenia. Am. J. Psychiatry. 151:1994;825-835.
10. Rothman K.J., Michels K.B. The continued unethical use of placebo controls. New Engl. J. Med. 331:1994;394-398.
11. Small J.G., Hirsch S.R., Arvanitis L.A., Miller B.G., Link C.G.G., Group S.S. Quetiapine in patients with schizophrenia: A high- and low-dose comparison with placebo. Arch. Gen. Psychiatry. 54:1997;549-557.
12. Volavka J. Are medication-free periods necessary for Phase III trials of new antipsychotic medications? Arch. Gen. Psychiatry. 55:1998;280-281.
13. World Medical Association, 1992. Declaration of Helsinki IV, World Medical Association, 41st World Medical Assembly, Hong Kong, September 1989. In: Annas, G.J., Grodin, M.A. (Eds.), The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. Oxford University Press, New York, pp. 339-342.
14. Wyatt R.J. Neuroleptics and the natural course of schizophrenia. Schizophr. Bull. 17:1991;325-351.
15. Young S.N. Risk in research - from the Nuremberg Code to the Tri-Council Code: implications for clinical trials of psychotropic drugs. J. Psychiatry Neurosci. 23:1998;149-155.
16. Zimbroff D.L., Kane J.M., Tamminga C.A.et al. Controlled, dose-response study of sertindole and haloperidol in the treatment of schizophrenia. Am. J. Psychiatry. 154:1997;782-791.