Antipsychotic prophylaxis is needed after remission from a first psychotic episode in schizophrenia patients: Results from an aborted randomised trial

Abstract

Objective. To assess the effect of withdrawal of antipsychotic treatment on relapse risk in remitted first-episode schizophrenia patients. Methods. First-episode 1-year stable and remitted outpatients with a schizophrenic disorder were randomly allocated to continuation of their antipsychotic regimen for at least 6 months (N = 9), or gradual withdrawal (N = 11). Primary outcome was the difference in cumulative relapse-free survival at 9 months. Results. Recruitment was terminated prematurely on 26 October 2005. The cumulative relapse-free survival was 88% (SE = 0.12) in the continuation and 18% (SE = 0.12) in the discontinuation group (P = 0.001) at 9 months follow-up. Conclusions. Discontinuation of antipsychotic medication markedly increases the risk of relapse in stable remitted first-episode schizophrenia patients. In future studies the topics of safety monitoring and sampling of patients should receive extra attention.

Key Words::

• First episode
• schizophrenia
• pyschopharmacology
• antipsychotics

Acknowledgements

Supported by a grant from ZonMw (Netherlands Organization for Health Research and Development) (2100.0057) and an unrestricted gift from Eli Lilly and Company^® (H6U-UT-LRAC). We thank Ingeborg van der Tweel, statistical advisor at the Centre for Biostatistics, University Utrecht.

Statement of interests

None to declare.