This 13-week, double-blind study evaluated the efficacy and safety of the atypical antipsychotic paliperidone palmitate (recently approved in the United States) versus placebo administered as monthly gluteal injections (after two initial doses given 1 week apart) in acutely symptomatic patients with schizophrenia. Patients (N=388) were randomly assigned (1 : 1 : 1 : 1) to paliperidone palmitate 50, 100, or 150 mg eq. or placebo. As the 150 mg eq. dose was administered to fewer patients (n=30) than planned, meaningful and definitive conclusions cannot be drawn from the results of this group. The change from baseline in Positive and Negative Syndrome Scale total score at endpoint showed improvement in both paliperidone palmitate 50 and 100 mg eq. groups but was significant only in the 100 mg eq. group (P=0.019). The paliperidone palmitate 50 (P=0.004) and 100 mg eq. (P<0.001) groups showed significant improvement in the Personal and Social Performance score from baseline to endpoint versus placebo. Common adverse events (in ≥2% of patients in any group) more frequent with paliperidone palmitate 50 or 100 mg eq. than placebo (≥5% difference) were headache, vomiting, extremity pain, and injection site pain. Treatment with paliperidone palmitate (100 mg eq.) was efficacious and all doses tested were tolerable.
aJohnson & Johnson Pharmaceutical Research and Development, L.L.C., Raritan, New Jersey, USA
bJohnson & Johnson Pharmaceutical Research and Development, Division of Janssen Pharmaceutica, N.V., Beerse, Belgium
cCommunity Clinical Research, Austin, Texas, USA
Correspondence to Dr Srihari Gopal, MD, MHS, Johnson & Johnson Pharmaceutical Research and Development, 1125 Trenton-Harbourton Road, Titusville, New Jersey 08560, USA
Tel: +1 609 730 2436; fax: +1 609 636 2233;
Received 16 October 2009 Accepted 1 March 2010