A 1-Year Double-Blind Study of 2 Doses of Long-Acting Risperidone in Stable Patients With Schizophrenia or Schizoaffective Disorder.
J Clin Psychiatry 2006;67(8):1194-1203
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Objective: This study examined the effects of 2
doses of long-acting risperidone injection in patients with
schizophrenia or schizoaffective disorder.
Method: 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 rehospitalization
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
Results: 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
Conclusion: 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.
Clinical Trials Registration: ClinicalTrials.gov