May 1997

The Rationale and Ethics of Medication-Free Research in Schizophrenia

Author Affiliations

From the Department of Psychiatry, University of Maryland School of Medicine and Maryland Psychiatric Research Center, Baltimore (Dr Carpenter); University of Pittsburgh School of Medicine, Psychosis Research Program, Western Psychiatric Institute and Clinic, Pittsburgh, Pa (Dr Schooler); and Albert Einstein College of Medicine, Department of Psychiatry, Long Island Jewish Medical Center, Hillside Hospital, Glen Oaks, NY (Dr Kane).

Arch Gen Psychiatry. 1997;54(5):401-407. doi:10.1001/archpsyc.1997.01830170015002

Schizophrenia research is receiving intense scrutiny from an ethical perspective. Medicationfree protocols present a most vexing dilemma in that they greatly enhance the opportunity for advancing knowledge but also raise the prospect of withholding known effective treatment. In this article, we discuss the purpose of medication-free protocols in new drug development and in nontreatment research. Potential benefits and risks associated with drug discontinuation are evaluated, and methods for minimizing risk and increasing benefits are proposed as guidelines for the protection of individual subjects. The complex problem of informed consent also is addressed. Medication-free research in schizophrenia is difficult, but it can be conducted relatively safely with freely consenting, competent subjects. Assurance that studies meet this standard is required. We believe that such investigations can meet high standards of ethics and subject protection, and that a radical revision of procedures for research review and implementation is not indicated.