Late-breaking Research Reports

نویسنده

  • Robert Rosenheck
چکیده

Background: Medication non-adherence is a major reason for poor outcomes in schizophrenia. Long-acting injectable (LAI) risperidone microspheres, the first LAI second generation antipsychotic (SGA), may improve adherence and thereby outcomes, but has not been tested in a long-term randomized trial of unstable patients, against flexibly prescribed oral treatment. Methods: Patients with schizophrenia or schizo-affective disorder who had been hospitalized within the past two years, o r j u d g e d t o b e a t r i s k o f hospitalization because of increasing psychiatric service use, were randomly a s s i g n e d t o L A I r i s p e r i d o n e b i-weekly 12.5–50 mg/injection, or to the psychiatrist's choice of oral antipsychotics (N=369). The primary intention-to-treat endpoint, psychiatric hospitalization, was documented with Department of Veterans Affairs administrative data, supplemental patient interviews, and r e v i e w o f d i s c h a r g e s u m m a r i e s f r o m n o n-VA admissions. Symptoms and quality of life were assessed through blinded video-conference interviews. The duration of the trial after assignment was two years. Results: Most patients were hospitalized either at randomization, or within t h e p r e v i o u s t w o y e a r s , o r w e r e a t c u r r e n t r i s k. M o s t p a r t i c i p a n t s a l s o acknowledged problems with medication adherence, and with alcohol or d r u g u s e. O v e r t wo years, we have determined whether LAI risperidone showed any difference over oral anti-psychotics (virtually all SGAs) on time to first psychiatric hospitalization or time to all cause discontinuation of randomized treatment. Mixed models using up to 18 months of data have evaluated the significance of any advantage of LAI risperidone on measures of psychiatric symptoms, quality of life, substance abuse, neurological side effects, weight gain or reduction of health services use. Conclusions: This study, l a s t i n g o v e r t w o y e a r s , h a s a s s e s s e d …

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تاریخ انتشار 2010