Pharmacopsychiatry 2010; 43(2): 66-72
DOI: 10.1055/s-0029-1239541
Original Paper

© Georg Thieme Verlag KG Stuttgart · New York

Prospective, Open Study of Long-Acting Injected Risperidone versus Oral Antipsychotics in 88 Chronically Psychotic Patients

P. Girardi1 , G. Serafini1 , M. Pompili1 , 2 , M. Innamorati3 , R. Tatarelli1 , R. J. Baldessarini2
  • 1Department of Psychiatry, Sant’Andrea Hospital, Sapienza University of Rome, Rome, Italy
  • 2Harvard Medical School, McLean Division of Massachusetts General Hospital, Boston, MA, USA
  • 3Department of Psychology, Università Europea di Roma, Rome, Italy
Further Information

Publication History

received 27.03.2009 revised 03.08.2009

accepted 06.08.2009

Publication Date:
22 January 2010 (eFirst)


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.



Dr. G. Serafini

Department of Psychiatry

University of Rome

Sant’ Andrea Hospital

1037 Via di Grottarossa

00189 Rome


Phone: +39/06/3377 5280

Fax: +39/06/3377 5342