SAN FRANCISCO — Post hoc analysis data presented at the APA annual meeting demonstrated that Vraylar, made by Allergan, may offer benefits for cognition symptoms in patients with schizophrenia.
“Individuals with schizophrenia have deficits in diverse areas of cognitive functioning, including attention and processing speed, and cognitive deficits have been associated with poor functional outcomes in schizophrenia,” Roger S. McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, and head of the Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, told Healio Psychiatry. “We wanted to better understand if cariprazine could address these deficits.”
The researchers analyzed data from a phase 3, randomized, double-blind, placebo- and active-controlled study to determine the effects of cariprazine on a computerized performance-based cognitive measure — the Cognitive Drug Research (CDR) System attention battery — among patients with schizophrenia.
They randomly assigned patients to receive either placebo, cariprazine 3 or 6 mg/day, or aripiprazole 10 mg/day for 6 weeks of double-blind treatment.
McIntyre and colleagues examined cognitive effects using two composite scores from the CDR system: Power of Attention (PoA), which measured focused attention, and Continuity of Attention (CoA), which measured sustained attention. They measured the median changes from baseline to week 6 in all patients, as well as in patients with higher levels of cognitive impairment.
Analysis indicated that the cariprazine 3-mg group showed an improvement from baseline to study endpoint in the focused attention measure while the other groups showed a decrease. Cariprazine 3 mg demonstrated superiority over placebo (P = .0036) and aripiprazole (P = .0006), while the 6-mg group showed a smaller decline compared with aripiprazole (P = .026), but not placebo (P = .1272), according to the results. In patients with higher baseline cognitive impairment, all groups showed improvement in the focused attention measure, with the 3-mg group demonstrating superiority over placebo (P = .008) and aripiprazole (P = .0064).
The results revealed that both cariprazine dose groups showed a significant improvement in the sustained attention measure compared with placebo (3 mg, P = .0005; 6 mg, P = .0168) in the overall population. Further, sustained attention scores significantly improved in patients with higher cognitive deficit at baseline compared with placebo for cariprazine 3 mg (P = .0012), cariprazine 6 mg (P = .0073) and aripiprazole (P = .016).
“These results suggest that cariprazine, as compared with aripiprazole, may provide benefits for cognitive symptoms in patients with schizophrenia,” McIntyre said. – by Savannah Demko
McIntyre RS, et al. Effects of Cariprazine on Attentional Processes in Patients with Schizophrenia: Post Hoc Analysis from a Randomized, Controlled Phase 3 Study. Presented at: APA Annual Meeting; May 18-22, 2019; San Francisco.
Disclosures: McIntyre reports consulting for Allergan.