By Jill Stein
PARIS -- July 1, 2009 -- Risperidone long-acting injectable (RLAI) is effective and well tolerated for the treatment of recent-onset schizophrenia, researchers stated here on June 30 at the 9th World Congress of Biological Psychiatry (WCBP).
Little is known about the use of long-acting injectable antipsychotics in recent-onset schizophrenia, and new atypical long-acting injectable psychotropic medications like RLAI may be a viable treatment option in this population, according to the researchers.
"Long-acting injectable antipsychotics have been traditionally reserved for treating poorly compliant, uncooperative, and severely ill patients with chronic schizophrenia," the authors noted in their poster presentation.
"Early in the course of illness, there are sound clinical reasons for using these agents," they wrote. For example, incomplete adherence to antipsychotics is common with high rates of relapse and incomplete symptom remission. Also, the early phase of illness can be a critical period since an aggressive relapsing course may produce accruing morbidity and persistent deficits, they added.
Jonathan Rabinowitz, PhD, Bar Ilan University, Ramat-Gan, Israel, and colleagues reported results in 302 patients with early-onset (<=2 years) schizophrenia who were treated with RLAI 25 to 50 mg injection every 14 days as part of a 6-month, open-label, flexible-dose, phase 4 trial. Overall, 86% of patients completed the study.
There were statistically significant improvements from baseline to last observation carried forward endpoint on Positive and Negative Syndrome Scale total (P < .0001); Clinical Global Impression of Severity (P < .0001); Global Assessment of Functioning (P < .0001); Short Form-36 Physical component summary (P < .001); and Short Form-36 Mental component summary (P < .001).
For Clinical Global Impression of Change endpoint ratings, 12.6% of patients were considered to be very much improved, 26.5% much improved, and 37.4% minimally improved. Overall, 17.3% were unchanged, 2.7% were minimally worse, and 3.4% were much worse.
RLAI was generally well tolerated. Dropout rates were low (16.2%) compared with other similar studies of recent-onset patients.
Overall, the results suggest that using a long-acting injectable antipsychotic may improve treatment adherence and possibly effectiveness in recent-onset schizophrenia, according to the authors.
Funding for this study was provided by Janssen-Cilag.
[Presentation title: Efficacy and Tolerability Among Patients With Recent Onset Schizophrenia Treated With Long-Acting Injectable Risperidone - PROPEL Study. Abstract P-28-011]
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