Effects of early clozapine treatment on remission rates in acute schizophrenia (EARLY)

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Achieving symptomatic remission quickly after the onset of psychotic symptoms is the critical objective in schizophrenia treatment and determines the subsequent disease course. In this context, only every second patient with acute schizophrenia achieves symptomatic remission within three months of initiating antipsychotic treatment, meaning that half of patients do not achieve this key objective. Increasing the likelihood to achieve symptomatic remission in acute schizophrenia will improve the overall outcome, reduce disease-associated burden and potentially prevent mid- and long-term disease chronicity. With this randomized, double-blind, parallel-group multicentre trial we aim to provide evidence for the superior efficacy of the ‘last resort’ antipsychotic clozapine compared to one of the most effective second-generation antipsychotics (SGAs), olanzapine, in acute schizophrenia patients who do not meet the criteria for treatment-naive or treatment-resistant schizophrenia. Our target population represents the largest group of schizophrenia patients; these patients are frequently hospitalized and receive ~20% of all psychiatric inpatient treatments in Germany. A total of 220 patients from eight academic centres with acute schizophrenia will be randomized to a double-blind, eight-week treatment with either clozapine or olanzapine. The primary endpoint is the number of patients in symptomatic remission at the end of week eight according to the international consensus criteria (‘Andreasen criteria’). Secondary endpoints include e.g. symptom severity, disease severity, global functioning, cognition, side-effect dimensions and patients’ and relatives’ view on treatment.