Effectiveness of antipsychotics in first-episode schizophrenia and schizophreniform disorder on response and remission: An open randomized clinical trial (EUFEST)
Received 3 March 2009; received in revised form 3 August 2009; accepted 16 September 2009. published online 12 October 2009.
Abstract
Background
Predefined response and remission criteria may hold more clinical relevance than mean scores on rating scales. We compared the effectiveness of low doses of haloperidol and regular doses of second generation antipsychotics (SGAs) on ≥50% response and remission.
Methods
In an open randomized clinical trial in 14 countries, 498 unselected first-episode patients with schizophrenia were assigned to haloperidol (1–4mg/d; n=103), amisulpride (200–800mg/d; n=104), olanzapine (5–20mg/d; n=105), quetiapine (200–750mg/d; n=104), or ziprasidone (40–160mg/d; n=82). Primary outcomes were ≥50% response and remission within 12months, as measured with the Positive and Negative Syndrome Scale. Analysis was by intention-to-treat.
Results
Within 12months, the proportions of patients with ≥50% response were 37% for haloperidol, 67% for amisulpride, 67% for olanzapine, 46% for quetiapine, and 56% for ziprasidone. Comparisons with haloperidol showed a higher likelihood for ≥50% response with amisulpride (hazard ratio [HR] 2.27, [95% CI 1.51–3.42]), olanzapine (HR 2.07 [1.38–3.10]), and ziprasidone (HR 1.62 [1.02–2.56]). Within 12months, the proportions of patients in remission were 17% for haloperidol, 40% for amisulpride, 41% for olanzapine, 24% for quetiapine, and 28% for ziprasidone. Comparisons with haloperidol showed a better chance for remission on amisulpride (HR 2.49, [95% CI 1.43–4.35]), olanzapine (HR 2.58 [1.48–4.48]), quetiapine (HR 1.96 [1.06–3.64]), and ziprasidone (HR 2.03 [1.07–3.87]).
Conclusions
Substantial proportions of first-episode patients with schizophrenia showed clinically meaningful response and remission rates within 12months. The proportions of response and remission were higher for most SGAs as compared to haloperidol.
fDepartment of Psychiatry, University of Naples SUN, Naples, Italy
Corresponding author. Department of Epidemiology (room FA 40), University Medical Centre Groningen, PO Box 30001, NL - 9700 RB Groningen, The Netherlands. Tel.: +31 50 3611808; fax: +31 50 3614493.
ABSTRACT