This poster was presented at the 30th annual Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.
Background: Although currently approved antipsychotics effectively treat positive symptoms of schizophrenia, treatments that improve negative symptoms remain an unmet need. Post hoc analyses investigated the efficacy of cariprazine in patients with moderate/severe negative symptoms of schizophrenia.
Methods: Data were pooled from 2 randomized, double-blind, placebo- and active-controlled cariprazine studies in patients with acute schizophrenia (NCT00694707, NCT01104766). Analyses included patients with Positive and Negative Syndrome Scale factor scores for negative symptoms (PANSS-FSNS) _24, PANSS-FS for positive symptoms (PANSS-FSPS) _19, and scores _4 on _2 of 3 PANSS items (N1, N4, N6). Changes from baseline to week 6 in PANSS-FSNS were evaluated for placebo, cariprazine 1.5-3 and 4.5-6 mg/d, risperidone 4 mg/d, and aripiprazole 10 mg/d.
Results: The least squares mean difference (LSMD) in change from baseline in PANSS-FSNS was statistically significant versus placebo for cariprazine (1.5-3 mg/d=-2.0, P=.0179; 4.5-6 mg/d= 3.4, P=.0002) and risperidone (-2.8, P=.0149), but not aripiprazole (-1.0, P=.3265); LSMD was also significant for cariprazine 4.5-6 mg/d versus aripiprazole ( 2.4 [ 4.5, -0.4], P=.0197). After adjusting for positive symptom changes, LSMDs versus placebo remained significant for cariprazine (1.5-3 mg/d=-1.4, P=.0322; 4.5-6 mg/d=-2.1, P=.0038) but not risperidone (-1.1, P=.2204). PANSS-FSNS response (_20% reduction from baseline) rates were significantly higher with cariprazine (1.5-3 mg/d=54.3%, P=.0194; 4.5-6 mg/d=69.7%, P=.0001) than placebo (35.4%).
Conclusion: In patients with acute schizophrenia and moderate/severe negative symptoms, significant improvement in negative symptoms was seen for cariprazine and risperidone versus placebo, but not for aripiprazole. Only cariprazine was associated with improvement in negative symptoms after adjusting for positive symptom improvement.