Different safety profiles of risperidone and paliperidone extended-release: a double-blind, placebo-controlled trial with healthy volunteers

Human Psychopharmacology: Clinical and Experimental, 05/17/2012

The results suggest that paliperidone extended–release may have a better safety profile than risperidone in terms of negative subjective experiences and cognitive function among normal volunteers.


  • Participants (n = 32) received a fixed dose of one of three study medications for three consecutive days: 6 mg of paliperidone ER, 3 mg of risperidone, or placebo.
  • Subjects were evaluated at baseline and after the first and third administrations of the medications by using the Neuroleptic-Induced Deficit Syndrome Scale and the Scale for the Assessment of Negative Symptoms.
  • Cognitive function was measured at baseline and after the third administration of the medications by using the computerized neuropsychological test.


  • Risperidone was associated with more detrimental subjective experiences compared with paliperidone ER and placebo (p < .05), and these differences persisted after controlling for mental and physical sedation.
  • Analysis of computerized neuropsychological test variables revealed significant differences in the changes in Stroop word-color test results from baseline between the paliperidone ER and risperidone groups (p < .005) and between the placebo and risperidone groups (p < .005).

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