A 1-year double-blind study of 2 doses of long-acting risperidone in stable patients with schizophrenia or schizoaffective disorder

Department of Psychiatry, Keck School of Medicine of the University of Southern California, Los Angeles, USA.
The Journal of Clinical Psychiatry (Impact Factor: 5.14). 09/2006; 67(8):1194-203.
Source: PubMed

ABSTRACT This study examined the effects of 2 doses of long-acting risperidone injection in patients with schizophrenia or schizoaffective disorder.
This 52-week, prospective, randomized, double-blind, multicenter, international study included clinically stable outpatients with schizophrenia or schizoaffective disorder (DSM-IV criteria). Settings included physicians' offices and clinics. Patients received a fixed dose of long-acting risperidone (25 or 50 mg) every 2 weeks. Primary outcome was time to relapse, defined as either re-hospitalization or other exacerbation criteria. Other assessments included the Positive and Negative Syndrome Scale, Clinical Global Impressions-Severity of Illness scale, and functional and quality-of-life measures. Safety was assessed via treatment-emergent adverse events, laboratory tests, and movement disorder rating scales. Data were collected from December 2002 to September 2004.
A total of 324 patients were randomized to 25 mg (N = 163) or 50 mg (N = 161) of long-acting risperidone. Time to relapse was comparable (p = .131) for both groups. Projected median time to relapse was 161.8 weeks (95% CI = 103.0 to 254.2) with 25 mg and 259.0 weeks (95% CI = 153.6 to 436.8) with 50 mg. One-year incidences of relapse were 21.6% (N = 35) and 14.9% (N = 24), respectively (p = .059). Psychiatric hospitalization was the reason for relapse for 16 (10%) in the 25-mg group and 10 (6%) in the 50-mg group. Patients experienced statistically significant but modest improvements at endpoint in most measures (i.e., psychotic symptoms, functioning, movement disorder severity) with both doses, with no significant between-group differences.
In this 1-year study, long-acting risperidone was associated with low relapse and rehospitalization rates, indicating that doses of 25 to 50 mg are appropriate for long-term treatment in schizophrenia.

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    • "For example, a 12-week, doubleblind , placebo-controlled randomized study of 400 patients with schizophrenia receiving either 25-, 50-or 75 mg biweekly intramuscular injections of placebo or long-acting risperidone found significant improvement on the positive and negative syndrome scale (PANSS) scores for long-acting risperidone relative to placebo (Kane et al., 2003). In another randomized, double-blind 52-week study with risperidone long-acting injectable 25 mg or 50 mg every 2 weeks (N=324), risperidone long-acting injectable 50 mg had a lower rate of relapse and also significant improvements in psychosocial functioning (Simpson et al., 2006). "
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