Enhancing the technology of clinical trials and the trials model to evaluate newly developed, targeted antidepressants

Martin M. Katz, Uriel M. Halbreich, Charles L. Bowden, Alan Frazer, Roger M. Pinder, A. John Rush, David P. Wheatley, Barry D. Lebowitz

Research output: Contribution to journalReview articlepeer-review

18 Scopus citations

Abstract

Concern about disappointing results from recent multi-center trials of new antidepressants prompted several ACNP workshops on "improving the technology of clinical trials." The workshops focused on technical problems, such as patient screening, reliability of clinical ratings, and the role of the placebo control. They aimed to determine how to more effectively apply the current clinical trials model for evaluating antidepressant drugs. The problems confronting the field of clinical trials, however, extend beyond technology. They also included conceptual issues concerning changes in the understanding of depressive disorders and of the multiple actions of antidepressant drugs. Such problems have been further complicated by the rapidly changing field of drug development itself, which is continually refining the targeting of new antidepressant agents. Drugs are increasingly being developed to try to change specific behavioral facets more rapidly and may be less likely, therefore, to act initially on "whole" disorders. To address such issues, a symposium was held in Rhodes in 2000 that focused on such conceptual changes with the goal of developing recommendations to revise the clinical evaluation model. Its purpose was to integrate new knowledge on depression and the mechanisms of action of antidepressant drugs toward developing more efficient methods of drug development. Since the evaluation process will eventually require changes in governmental policy, senior staff from the National Institute of Mental Health (NIMH) and Food and Drug Administration (FDA) participated as well as members of academia, industry and clinical practice. Recommendations for altering clinical trial methodology were made in four areas: patient selection, methodology of evaluation, measuring onset of action, and FDA and NIMH perspectives on current practice. This article discusses these four areas and presents the consensus of the panel participants.

Original languageEnglish (US)
Pages (from-to)319-328
Number of pages10
JournalNeuropsychopharmacology
Volume27
Issue number3
DOIs
StatePublished - Sep 2002

Keywords

  • Antidepressant
  • Antidepressant drug development
  • Clinical methodology
  • Clinical trial
  • Componential behavioral approach
  • Onset of drug action

ASJC Scopus subject areas

  • Pharmacology
  • Psychiatry and Mental health

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