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Weekly UpdatesSAN FRANCISCO -- Risperidone in a long-acting, injectable form is associated with significantly fewer relapses among patients with bipolar I disorder, according to a placebo-controlled study involving 303 patients.
During 24 months of follow-up, 30% of the patients in the risperidone long-acting injectable (LAI) group relapsed, compared with 56% of the patients in the placebo group, a significant difference, wrote Dr. Jorge A. Quiroz and his colleagues in a poster presentation at the annual meeting of the American Psychiatric Association. The study was funded by Johnson & Johnson Pharmaceutical Research & Development. Dr. Quiroz is employed by this division of Johnson & Johnson.
Patients were eligible for the study only if they were aged 18-65 years, had a body mass index of 17-33 kg/[m.sup.2], and had been diagnosed with bipolar I disorder as defined by DSM-IV TR. Patients were excluded if they failed to respond to oral or LAI risperidone over a 3-week period. All risperidone responders were stabilized on 12.5-50 mg of risperidone LAI for 26 weeks before being randomized to receive either a placebo or the same dose of risperidone LAI.
Investigators judged a patient to have relapsed if they met DSM-IV TR criteria for a manic, hypomanic, mixed, or depressive episode; required treatment intervention with any mood stabilizer, antipsychotic medication, benzodiazepine, or antidepressant medication; needed to be hospitalized for any bipolar mood episode; had a Young Mania Rating Scale score above 12, a Mont-gomery-Asberg Depression Rating Scale score above 12, or a Clinical Global Impressions-Severity score above 4; or if the patient required an increase in risperidone LAI dosage or supplementation with oral risperidone.
Patients in the risperidone LAI group were only 40% as likely to experience a relapse as patients in the placebo group, a significant difference. In addition, the time to relapse for patients in the risperidone LAI group was significantly longer than those in the placebo group. Kaplan-Meier estimates of 9-month relapse rates were 30% in the risperidone LAI group and 60% in the placebo group. The investigators calculated that one would have to treat 3.3 patients over 9 months to achieve one favorable outcome.
Three patients died during the study, one because of a perforated duodenal ulcer and peritonitis, one after an accidental fall, and another because of suicide.
The authors emphasized that the use of risperidone LAI for bipolar I disorder is investigational.
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