Investigators found that patients receiving cariprazine showed significant improvement in cognitive symptoms compared to patients receiving aripiprazole or placebo therapy.
Willie Earley, MD
A recent study has found that cariprazine can significantly improve cognition symptoms in patients with schizophrenia.
The study, which was presented at the 2019 Annual Meeting of the American Psychiatric Association, found that cariprazine 3mg improved cognitive symptoms in the general study population compared to both placebo and aripiprazole.
Willie Earley, MD, study author and associate vice president of clinical development at Allergan, told MD Magazine® that investigators sought to compare cariprazine with other standard drugs of care.
“The theory is that this D3 binding will have some improvement in cognition, reward, motivation and some of the other things. We have seen, in a previous study with cariprazine compared with risperidone, that cariprazine has an effect on negative symptoms, which differs from risperidone. So, we see some differences in effect between our drug and the standard drugs of care like risperidone and now aripiprazole,” Earley explained.
Investigators included 604 patients from 57 centers in the US, Ukraine, Romania, and Russia with a diagnosis of schizophrenia within their phase 3, randomized, double-blind, placebo- and active-controlled study. Patients were randomized 1:1:1:1 to placebo, aripiprazole 10mg per day, or cariprazine at doses of either 3mg per day or 6mg per day.
A total of 149 were included in the placebo group, 150 to aripiprazole, 151 to cariprazine 3mg, and 154 to cariprazine 6mg. To be included, patients were required to have a Positive and Negative Syndrome Scale (PANSS) total score between 80 and 120, score of 4 or more on a least 2 of 4 PANSS items and Clinical Global Impressions-Severity (CGI-S) score of 4 or more.
The primary efficacy parameter was PANSS Total score change from baseline to week 6. Cognitive effects were assessed using two composite scores from the Cognitive Drug Research (CDR)— the Power of Attention (PoA) and Continuity of Attention (CoA). Investigators used the Wilcoxon rank-sum test to statistically analyze between-group differences.
At the end of the study, cariprazine 3mg showed improvement over baseline in PoA while the other groups showed a decline. Authors noted that cariprazine 3mg was significantly superior to placebo therapy (P=.0036) and aripiprazole (P=.0006). Additionally, cariprazine 6mg showed a significantly smaller decline than aripiprazole (P=.0260), but not placebo therapy (P=.1272). In patients who had higher baseline cognitive impairments, all groups improved on PoA and the cariprazine 3mg group was significantly superior to placebo (P=.0080).
For CoA, both groups receiving cariprazine showed significant improvement over the placebo (3mg, P=.005; 6mg, P=.0168). In patients with higher cognitive deficit at baseline, CoA scores showed significant improvement in both groups receiving cariprazine (3mg, P=.0012; 6mg, P=.0073) and in the group receiving aripiprazole (P=.0160) compared to placebo.
This study, titled “Effects of Cariprazine on Attentional Processes in Patients With Schizophrenia: Post Hoc Analysis From a Randomized, Controlled Phase III Study,” was presented at APA 2019 in San Francisco, CA.