title: Randomized trial of clozapine vs. risperidone in treatment-naïve first-episode schizophrenia: results after one year.
abstract: In first-episode patients with psychosis, clozapine may be potentially valuable as an initial treatment seeking to limit early on clinical and cognitive deterioration. Nevertheless, until recently its restricted use has limited the study of this possibility. Our research group is developing a non-commercial, multicentric and open label study on the differential efficacy between clozapine and risperidone in first-episode schizophrenia. In this paper, we present the results related to clinical variables after a one-year follow-up. So far, we have recruited 30 patients diagnosed with schizophrenia or schizophreniform disorder with illness duration of less than two years. The patients had not received any previous treatment and they were randomized to treatment with clozapine or risperidone. Our results indicate that on average, patients on clozapine adhered to their original treatment for a longer time period than patients on risperidone. By last observation carried forward (LOCF) analysis, patients on clozapine and risperidone displayed similar clinical improvements, although marginally greater improvements in positive and total symptoms scores were found in the clozapine group. At the 12-month point we observed a marginal improvement in negative symptom scores in patients on clozapine. Subjective secondary effects, as measured with the Udvalg for KliniskeUndersøgelser (UKU) scale, correlated negatively with negative symptoms at follow-up. Our data, although preliminary, suggest that clozapine may have a slightly superior efficacy in the initial year of treatment of first-episode treatment-naïve patients with schizophrenia, and this can be explained for the most part by greater adherence to this treatment.
authors.affiliation: Department of Psychiatry, Hospital 12 de Octubre, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Sanz-Fuentenebro
authors.forename: Diana
authors.initials: D
authors.lastname: Taboada
authors.forename: Tomás
authors.initials: T
authors.lastname: Palomo
authors.forename: María
authors.initials: M
authors.lastname: Aragües
authors.forename: Santiago
authors.initials: S
authors.lastname: Ovejero
authors.forename: Cristina
authors.initials: C
authors.lastname: Del Alamo
authors.forename: Vicente
authors.initials: V
authors.lastname: Molina
mesh_terms: D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001835:Body Weight / Q000187:drug effects; D003024:Clozapine / Q000627:therapeutic use*; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D038321:Glycemic Index; D006801:Humans; D050356:Lipid Metabolism / Q000187:drug effects; D008297:Male; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D003024:Clozapine; D018967:Risperidone
keywords: Clozapine; First-episode schizophrenia; Risperidone; Treatment naïve