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Related Experiment Videos

Schizophrenia: do we really need placebo-controlled studies?

J G Storosum1, A J Elferink, B J van Zwieten

  • 1Medicines Evaluation Board of The Netherlands, Rijswijk.

European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology
|February 3, 1999
PubMed
Summary

Placebo control is essential for demonstrating treatment efficacy in short-term schizophrenia studies. Non-placebo-controlled trials may not adequately capture true treatment effects, especially regarding responder rates.

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Area of Science:

  • Psychiatry
  • Clinical Psychology
  • Pharmacology

Background:

  • Short-term efficacy studies in schizophrenia often rely on placebo controls.
  • The necessity of placebo control in these studies remains a subject of debate.
  • Alternative control groups are being explored to assess treatment effectiveness.

Purpose of the Study:

  • To evaluate the necessity of placebo control in short-term efficacy studies for schizophrenia.
  • To compare efficacy outcomes between placebo-controlled and positive-controlled (non-placebo) studies.
  • To determine if non-placebo-controlled studies adequately demonstrate treatment efficacy.

Main Methods:

  • Comparative analysis of efficacy results from placebo-controlled versus positive-controlled studies.

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  • Focus on short-term treatment of chronic schizophrenia.
  • Examination of both mean improvement scores (e.g., Brief Psychiatric Rating Scale - BPRS) and responder rates.

    • Main Results:

    • Placebo arms in some studies showed worsening or minimal improvement on the BPRS.
    • Mean improvement in haloperidol arms was comparable across placebo-controlled and non-placebo-controlled studies.
    • Responder rates in non-placebo-controlled studies were often similar to placebo arms in placebo-controlled studies.
    • Dropout rates were higher in placebo arms, particularly due to insufficient response in active treatment arms of non-placebo-controlled studies.

    Conclusions:

    • Placebo control is necessary to adequately demonstrate efficacy in short-term schizophrenia studies.
    • Responder rates, a clinically relevant measure, showed significant variability in placebo arms, underscoring the need for placebo control.
    • Current alternatives to placebo-controlled studies are insufficient for proving efficacy in schizophrenia patients, though consensus on responder definitions is needed.