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

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.