• antipsychotic agents;
  • epidemiologic research design;
  • Europe;
  • longitudinal studies;
  • multicentre studies;
  • schizophrenia;
  • treatment outcome

Objective:  The objective of the European Schizophrenia Outpatient Health Outcomes (SOHO) study is to understand the comparative costs and outcomes of antipsychotic drug treatment, with specific focus on olanzapine. The study will also provide a large database for research into the treatment and outcome of schizophrenia. The role of observational studies in the assessment of the effectiveness of antipsychotic agents is reviewed, and the rationale, design and recruitment issues surrounding the SOHO study are presented.

Method:  SOHO is a 3-year, prospective, observational study of the health outcomes associated with antipsychotic treatment in Europe.

Results:  Over 10 000 patients have been recruited from 10 countries. Baseline evaluation included measures of clinical status, social functioning, quality of life, service use and pharmacological treatment. Patients will be followed for 3 years.

Conclusion:  The SOHO study will complement randomized controlled trial findings on the treatment of schizophrenia and will address relevant clinical and policy research questions.