Patients with schizophrenia taking the antipsychotic amisulpride showed greater symptom improvements after one year compared with those taking aripiprazole or olanzapine, according to a study in Lancet Psychiatry. (Intravenous amisulpride was approved this past February to treat postoperative nausea/vomiting; it is not approved for schizophrenia in the United States but is approved in Europe and licensed in over 50 countries.)
Erik Johnsen, M.D., of Haukeland University Hospital in Bergen, Norway, and colleagues randomized 144 adults diagnosed with schizophrenia to receive oral amisulpride, aripiprazole, or olanzapine for 52 weeks. The trial was designed as semi-blinded; that is, the patients and their psychiatrists knew which medication the patients were taking, but the researchers who conducted periodic evaluations did not. The researchers assessed the participants’ symptoms using the Positive and Negative Syndrome Scale (PANSS) and side effects at baseline and weeks 1, 3, 6, 12, 26, 39, and 52 of the study.
After 52 weeks, the patients who were taking amisulpride had a PANSS total score reduction of 32.7 points, which was superior to improvements seen in patients taking aripiprazole (21.9 points) or olanzapine (23.3 points). Patients taking amisulpride saw greater improvements in positive symptoms (such as hallucinations and delusions) and general symptoms (such as anxiety and attention) than those taking aripiprazole or olanzapine. There were no differences between the groups when it came to improvements in negative symptoms (such as emotional or social withdrawal).
Twenty patients experienced at least one serious adverse event, such as readmission to a psychiatric hospital: four were taking amisulpride, 10 were taking aripiprazole, and six were taking olanzapine. There were no statistical differences among the study drugs with regard to risk of a serious adverse event or metabolic side effects such as weight gain.
“Results from clinical trials without a placebo control should be interpreted with caution,” Johnsen and colleagues wrote. “Nevertheless, it seems reasonable to surmise that in acutely psychotic patients starting treatment on a new oral antipsychotic, a substantial and clinically relevant improvement [with amisulpride] can be expected.”
“This study is interesting in that it used a pragmatic design. The result is that the treatments were administered in a manner that is similar to the way they are administered in the community," Stephen Marder, M.D., a professor of psychiatry and biobehavioral sciences at the University of California, Los Angeles, told Psychiatric News. Marder, who was not involved with the study, noted that the differences in PANSS scores between amisulpride and the other drugs corresponded to effect sizes of over 0.5—significant changes that a physician would notice quickly. “The advantages of amisulpride were substantial. I’m hopeful that studies like this may encourage industries to sponsor amisulpride studies in the United States.”
To read more on this topic, see the Psychiatric News article “Which Antipsychotics Are Best for Your Patients?”
(Image: iStock\FilippoBacci)
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