SAN ANTONIO, TX—Lurasidone was associated with medium to large treatment effect sizes in adult patients with schizophrenia who presented with prominent positive symptoms, a study presented at the U.S. Psychiatric & Mental Health Congress has found.
“Acute schizophrenia is characterized by the presence of positive symptoms, which increase the risk of behavioral disturbances and hospitalization,” noted Steven G. Potkin, MD, of the University of California-Irvine, Irvine, CAS, and colleagues.
To evaluate the efficacy of lurasidone in patients with acute schizophrenia with prominent positive symptoms, short-term data were pooled from 5 similarly designed, double-blind, placebo-controlled, 6-week studies.
The safety population included those randomly assigned to receive fixed-dose lurasidone 40mg, 80mg, 120mg, or 160mg daily or placebo.
Patients with prominent positive symptoms were defined as those with baseline Positive and Negative Syndrome Scale (PANSS) positive subscale score that was greater than baseline PANSS negative subscale score. Those without prominent positive symptoms had baseline PANSS positive subscale score that was less than or equal to baseline PANSS negative subscale score.
The majority of the patients were male with a mean age of 38 years and a mean age at illness onset of 24 years. About half had 4 or more prior hospitalizations.
In both subgroups, improvement in placebo-adjusted PANSS total score was significantly greater for every dose of lurasidone versus placebo.
“Larger effect sizes were generally observed in patients with schizophrenia with prominent positive symptoms compared to patients without prominent positive symptoms,” the authors noted. “These results may inform the design of future clinical trials in schizophrenia.”
The most common adverse events were somnolence, headache, akathisia, Parkinsonism, nausea, vomiting, and insomnia.