Treatment of Schizophrenia With Long-Acting Injectable Risperidone: A 12-Month Open-Label Trial of the First Long-Acting Second-Generation Antipsychotic
J Clin Psychiatry 2003;64(10):1250-1257
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Background: The long-term safety and
efficacy of long-acting injectable risperidone, the first
long-acting second-generation antipsychotic, were evaluated in
stable patients with schizophrenia.
Method: After a 2-week run-in period during
which patients with DSM-IV schizophrenia received flexible doses
of 1 to 6 mg of oral risperidone, patients received injections of
25 mg, 50 mg, or 75 mg of long-acting risperidone every 2 weeks
for 12 months. Severity of extrapyramidal symptoms was assessed
with the Extrapyramidal Symptom Rating Scale (ESRS), and efficacy
was assessed with the Positive and Negative Syndrome Scale
(PANSS). This study was conducted from March 29, 1999 to July 19,
Results: The subjects were 615 patients with
schizophrenia who received at least 1 injection of long-acting
risperidone. The 12-month trial was completed by 65% of patients.
Treatment was discontinued because of adverse events in 5% of
patients. Extrapyramidal symptoms as adverse events were reported
by 25% of the patients. Severity of extrapyramidal symptoms
(according to ESRS scores) was low at baseline and decreased in
each of the groups during the 12 months. The other most common
adverse events were anxiety in 24%, insomnia in 21%, psychosis in
17%, and depression in 14% of the patients. Little pain was
associated with the injections. Severity of symptoms of
schizophrenia was improved in each group, with significant
reductions in PANSS total scores (p < .01) and positive (p
< .01) and negative (p < .001) factor scores.
Conclusion: In terms of both safety and
efficacy, symptomatically stable patients with schizophrenia
benefit from being switched to long-acting injectable