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Psych Congress  

Cariprazine in Acute Exacerbation of Schizophrenia: A Fixed-Dose Phase III, Randomized, Double-Blind, Placebo- and Active-Controlled Trial

Authors  
Andrew Cutler, MD. Jeffrey Lieberman, MD. Shuyan Wan, PhD. Raffaele Migliore, MA. István Laszlovszky, PharmD, PhD. György Németh, MD, PhD. Suresh Durgam, MD.
Sponsor  
Forest Laboratories, Inc. and Gedeon Richter Plc

Objective: Cariprazine, an orally active and potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors, is in development for the treatment of schizophrenia and bipolar mania. Cariprazine previously demonstrated efficacy in patients with schizophrenia in Phase II and Phase III studies. This Phase III trial (NCT01104766) further evaluated the efficacy, safety, and tolerability of cariprazine in patients with acute exacerbation of schizophrenia.

Methods: This was an international, double-blind, placebo- and active-controlled, fixed-dose study. Patients with schizophrenia were randomized to cariprazine 3 mg/d (n=155), cariprazine 6 mg/d (n=157), aripiprazole 10 mg/d (n=152), or placebo (n=153) for 6 weeks of double-blind treatment. Primary and secondary efficacy parameters were change from baseline to Week 6 in PANSS total score and Clinical Global Impressions-Severity (CGI-S) score, respectively, analyzed using an MMRM approach.
Results: Cariprazine demonstrated significantly greater improvement than placebo on PANSS total scores (LSMD vs placebo: cariprazine 3 mg/d=-6.0, P=.0044; cariprazine 6 mg/d=-8.8, P<.0001) and CGI-S scores (LSMD: cariprazine 3 mg/d=-0.4, P=.0044; cariprazine 6 mg/d=-0.5, P<.0001) at Week 6. Aripiprazole also demonstrated significant differences versus placebo on both measures (LSMD: PANSS=-7.0, P=.0008; CGI-S=-0.4, P=.0001). The most common TEAEs (≥5% and twice the rate of placebo) were akathisia in the cariprazine 6 mg/d group, and abdominal discomfort and nausea in the aripiprazole group; most TEAEs were mild to moderate in severity. 

Conclusion: In patients with acute exacerbation of schizophrenia, cariprazine 3 and 6 mg/d demonstrated significant improvement compared with placebo on primary and secondary efficacy measures and was generally well tolerated.  

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