Cariprazine, which was approved by the Food and Drug Administration in 2015 to treat adults with schizophrenia and manic/mixed episodes of bipolar disorder, generated some excitement early on after trials suggested the medication led to improvements in positive and negative symptoms. But these trials were unable to determine whether the improvements in negative symptoms were directly from the medication or secondary to improvements in positive symptoms or comorbid depression (Psychiatric News, October 16, 2015).
As described in an article appearing today in Psychiatric News PsychoPharm, the authors of the current study sought to tease apart these two possibilities by assessing only patients with predominantly negative symptoms. Patients with long-term stable schizophrenia and predominant negative symptoms for more than six months were randomly assigned to once-daily cariprazine (3 to 6 mg/day) or risperidone (3 to 6 mg/day) for 26 weeks.
After 14 weeks, patients taking cariprazine began to show greater improvements in both negative symptoms (measured with the Positive and Negative Syndrome Scale, PANSS) and psychosocial functioning (measured using the Personal and Social Performance Scale, PSP) compared with patients on risperidone. By week 26, the cariprazine group had experienced an average decline of 8.90 points in the PANSS negative scores compared with a decline of 7.44 points in the risperidone group. For PSP, cariprazine patients saw a 14.30-point improvement compared with 9.66-point improvement for risperidone.
“The effect sizes were modest, but the study identified consistent advantages for cariprazine for a variety of measures,” John Kane, M.D., the chair of psychiatry at the Zucker Hillside Hospital in Glen Oaks, N.Y., told Psychiatric News. Kane has carried out clinical trials with cariprazine previously, but he was not involved with this trial. Given the lack of options for patients with elevated negative symptoms, “this was exactly the kind of study needed to advance the field of schizophrenia therapy,” he added.
For more on the trial and what the findings might mean for psychiatry, see “Study Suggests Cariprazine May Have Direct Effects on Negative Symptoms.”