Amisulpride and olanzapine followed by open-label treatment with clozapine in first-episode schizophrenia and schizophreniform disorder (OPTiMiSE): a three-phase switching study

Publication date: Available online 13 August 2018Source: The Lancet PsychiatryAuthor(s): René S Kahn, Inge Winter van Rossum, Stefan Leucht, Philip McGuire, Shon W Lewis, Marion Leboyer, Celso Arango, Paola Dazzan, Richard Drake, Stephan Heres, Covadonga M Díaz-Caneja, Dan Rujescu, Mark Weiser, Silvana Galderisi, Birte Glenthøj, Marinus J C Eijkemans, W Wolfgang Fleischhacker, Shitij Kapur, Iris E Sommer, René S KahnSummaryBackgroundNo established treatment algorithm exists for patients with schizophrenia. Whether switching antipsychotics or early use of clozapine improves outcome in (first-episode) schizophrenia is unknown.MethodsThis three-phase study was done in 27 centres, consisting of general hospitals and psychiatric specialty clinics, in 14 European countries and Israel. Patients aged 18–40 years who met criteria of the DSM-IV for schizophrenia, schizophreniform disorder, or schizoaffective disorder were treated for 4 weeks with up to 800 mg/day amisulpride orally in an open-label design (phase 1). Patients who did not meet symptomatic remission criteria at 4 weeks were randomly assigned to continue amisulpride or switch to olanzapine (≤20 mg/day) during a 6-week double-blind phase, with patients and staff masked to treatment allocation (phase 2). Randomisation was done online by a randomisation website; the application implemented stratification by site and sex, and applied the minimisation method for randomisation. Patients who were not in remission at 10 we...
Source: The Lancet Psychiatry - Category: Psychiatry Source Type: research