Safety and Efficacy of Long-Acting Risperidone in Schizophrenia: A 12-Week, Multicenter, Open-Label Study in Stable Patients Switched From Typical and Atypical Oral Antipsychotics

Jean-Pierre Lindenmayer, M.D.; Els Eerdekens, M.Sc.Ir.; Sally A. Berry, M.D., Ph.D.; and Marielle Eerdekens, M.D., M.B.A.

Background: The safety and efficacy of the first long-acting injectable atypical antipsychotic, risperidone, were assessed in stable patients with schizophrenia switched from oral antipsychotic medications.

Method: Data were collected between July 1, 2001, and October 25, 2002. The study population included patients from clinics, hospitals, and physicians' offices. After a 4-week run-in period, symptomatically stable patients with schizophrenia (DSM-IV) who had been taking haloperidol (N = 46), quetiapine (N = 45), or olanzapine (N = 50) received 25 mg of long-acting risperidone. The oral antipsychotics were continued for 3 weeks after the first injection of long-acting risperidone. Injections were administered every 2 weeks at 25 mg up to a maximum dose of 50 mg for 12 weeks in this multicenter, open-label study.

Results: Long-acting risperidone was well tolerated. Of the 141 patients who participated in the study, the most frequently reported adverse events were insomnia (16%), headache (15%), psychosis (11%), and agitation (11%). The mean increase in body weight was 0.4 kg. No other clinically relevant laboratory abnormalities or significant electrocardiogram changes were observed during the 12-week treatment. Extrapyramidal Symptom Rating Scale total scores were reduced during treatment with long-acting risperidone. Improvements in symptoms of schizophrenia were observed with long-acting risperidone at week 4 and continued through the 12-week treatment with significant reductions in total Positive and Negative Syndrome Scale (PANSS) scores at week 8 (-2.5, p < .01) and week 12 (-3.9, p < .001). At endpoint, 37% (50/135) of these stable patients were rated as clinically improved (>= 20% decrease in PANSS total scores).

Conclusions: Switching treatment from oral antipsychotics to long-acting risperidone without an intervening period of oral risperidone was safe and well tolerated. Long-acting risperidone also significantly reduced the severity of symptoms in these stable patients with schizophrenia.

(J Clin Psychiatry 2004;65:1084-1089)

Received Jan. 6, 2004; accepted June 7, 2004. From the Manhattan Psychiatric Center, New York University School of Medicine, New York, N.Y. (Dr. Lindenmayer); Johnson & Johnson Pharmaceutical Research and Development, Beerse, Belgium (Ms. Eerdekens and Dr. Eerdekens); and Johnson & Johnson Pharmaceutical Research and Development, Titusville, N.J. (Dr. Berry).

Dr. Lindenmayer has served as a consultant for Lilly, Pfizer, and Janssen; has received grant/research support from Janssen, Lilly, AstraZeneca, and Repligen; and has participated in speakers or advisory boards for Lilly, Abbott, AstraZeneca, and Bristol-Myers Squibb. Ms. Eerdekens, Dr. Berry, and Dr. Eerdekens are employees of Johnson & Johnson Pharmaceutical R&D.

Corresponding author and reprints: Jean-Pierre Lindenmayer, M.D., Manhattan Psychiatric Center-Nathan Kline Institute for Psychiatric Research, Ward's Island, New York, NY 10035 (e-mail: lindenmayer@nki.rfmh.org).