The PRIME North America randomized double-blind clinical trial of olanzapine versus placebo in patients at risk of being prodromally symptomatic for psychosis

I. Study rationale and design

T. H. McGlashan, R. B. Zipursky, D. Perkins, J. Addington, T. J. Miller, S. W. Woods, K. A. Hawkins, R. Hoffman, S. Lindborg, M. Tohen, Alan Breier

Research output: Contribution to journalArticle

146 Citations (Scopus)

Abstract

The first double-blind placebo-controlled clinical trial of an atypical neuroleptic medication is being conducted in symptomatic treatment-seeking patients meeting new diagnostic criteria for a putative prodromal syndrome. This identifies them as being at high risk for developing psychosis in the near future. The study aims include prevention of psychosis onset and disability, as well as palliation of ongoing symptomatology. This report presents the study rationale and design. Recent studies will be reviewed that have advanced our knowledge about the early course of schizophrenia and our ability to predict onset prospectively, advances that have rendered prodromal intervention research feasible and ethical. The study design has many novel features. It tests for prevention versus delay in psychosis onset, as well as for efficacy and safety in a newly defined clinical population. This has required the development of innovative clinical research assessment instruments and a new operational definition of psychosis onset. The integration of these novel elements into an otherwise typical clinical trial design is detailed. The companion report will address sample recruitment and the clinical phenomenology at baseline of this putative "prodromal" entity.

Original languageEnglish (US)
Pages (from-to)7-18
Number of pages12
JournalSchizophrenia Research
Volume61
Issue number1
DOIs
StatePublished - May 1 2003

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olanzapine
North America
Psychotic Disorders
Placebos
Clinical Trials
Prodromal Symptoms
Aptitude
Controlled Clinical Trials
Research
Antipsychotic Agents
Schizophrenia
Safety
Population

Keywords

  • Early intervention
  • Olanzapine
  • Prevention
  • Prodrome
  • Schizophrenia

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Behavioral Neuroscience
  • Biological Psychiatry
  • Neurology
  • Psychology(all)

Cite this

The PRIME North America randomized double-blind clinical trial of olanzapine versus placebo in patients at risk of being prodromally symptomatic for psychosis : I. Study rationale and design. / McGlashan, T. H.; Zipursky, R. B.; Perkins, D.; Addington, J.; Miller, T. J.; Woods, S. W.; Hawkins, K. A.; Hoffman, R.; Lindborg, S.; Tohen, M.; Breier, Alan.

In: Schizophrenia Research, Vol. 61, No. 1, 01.05.2003, p. 7-18.

Research output: Contribution to journalArticle

McGlashan, T. H. ; Zipursky, R. B. ; Perkins, D. ; Addington, J. ; Miller, T. J. ; Woods, S. W. ; Hawkins, K. A. ; Hoffman, R. ; Lindborg, S. ; Tohen, M. ; Breier, Alan. / The PRIME North America randomized double-blind clinical trial of olanzapine versus placebo in patients at risk of being prodromally symptomatic for psychosis : I. Study rationale and design. In: Schizophrenia Research. 2003 ; Vol. 61, No. 1. pp. 7-18.
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