Evidence for shortening the duration of clinical trials of antidepressants and a proposed paradigm for such studies

Martin M. Katz, Nancy Berman, Charles L. Bowden, Alan Frazer

Research output: Contribution to journalArticle

Abstract

The model for the clinical trial of putative antidepressants is older than 50 years. Recent failures resulted in several drug companies, citing excessive costs of lengthy multiweek trials, abandoning new drug development. Collateral problems include patients being maintained on ineffective drugs for 6 to 8 weeks, increasing the pain associated with the disorder. This study proposes an alternative model for testing new drugs that both shortens the clinical trial and broadens its aims to include a profile of the new drug's specific clinical actions. This alternative model makes it possible to uncover the drug's application to treatment of other mental disorders. It is based on recent findings that onset of action and a large proportion of an effective drug's positive effects, contrary to early reports, occur within the first 2 weeks. It uses an index of the 2-week "early improvement" to predict a 6-week outcome. Measuring effects on the dimensions of the disorder determined that effective antidepressants act on mood and behavioral components and that the Hamilton and new "multivantaged" methods can provide a profile of specific drug actions distinguished from nonspecific placebo effects, at 2 weeks. This early improvement is predictive of positive outcome of 6-week trials. Because of the implications of successful 2-week trials for reducing costs, providing data on specific clinical drug actions, potentially stimulating new drug development, and reducing patient suffering from extended treatment with ineffective drugs, a large sample, prospective study designed in accord with this test trial is recommended.

Original languageEnglish (US)
Pages (from-to)329-332
Number of pages4
JournalJournal of Clinical Psychopharmacology
Volume35
Issue number3
DOIs
StatePublished - Jun 13 2015

Keywords

  • Antidepressants
  • early improvement
  • multivantaged assessment
  • prediction
  • two week clinical trials

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)

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