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DOI: 10.1055/s-0029-1239541
© Georg Thieme Verlag KG Stuttgart · New York
Prospective, Open Study of Long-Acting Injected Risperidone versus Oral Antipsychotics in 88 Chronically Psychotic Patients
Publication History
received 27.03.2009
revised 03.08.2009
accepted 06.08.2009
Publication Date:
22 January 2010 (online)
Abstract
Introduction: A long-acting, injected, carbohydrate-microsphere preparation of risperidone (RLAI; Risperdal Consta®) is reported to be safe and effective in chronic psychotic illnesses but, as its long-term and comparative efficacy remain unclear, this study compared clinical status during oral antipsychotic treatment versus conversion to RLAI.
Methods: Psychotic patients (n=88; initial BPRS=93±5) were treated for 6 months with clinically chosen oral medication and then converted to biweekly RLAI for the first 6 months (6−6 months matched mirror comparison) and then for another 18 months. Clinical status in the two treatment periods and in the 18 months of follow-up was compared with measures including BPRS improvement (primary outcome), CGI variants and SF-36 ratings.
Results: RLAI (at a mean dose of 47 mg/2 weeks at six and up to 23.1±3.3 months) was associated with major improvements in all outcome measures (p<0.001). Initial BPRS scores fell by an average of 50% within six months; hospitalizations declined from 19.8% to 0%, and rates of adverse events were reduced by 2.5- to 7.4-fold. Such benefits were sustained during 18 months of follow-up with RLAI-treatment.
Conclusions: The findings are limited by the lack of a parallel control treatment, such as with oral risperidone or another antipsychotic, lack of blinded assessments, and a moderate number of subjects. Nevertheless, the findings add to indications that RLAI can be an effective and well-tolerated treatment-option for chronically psychotic patients.
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Correspondence
Dr. G. Serafini
Department of Psychiatry
University of Rome
Sant’ Andrea Hospital
1037 Via di Grottarossa
00189 Rome
Italy
Phone: +39/06/3377 5280
Fax: +39/06/3377 5342
Email: gianluca.serafini@uniroma1.it