Leslie Citrome 1 , Suresh Durgam , Kaifeng Lu , Paul Ferguson , István Laszlovszky Show Affiliations »
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OBJECTIVE: Although most patients with schizophrenia are not aggressive, individuals with the disorder have increased risk of hostile behavior. Cariprazine , a dopamine D3 and D2 receptor partial agonist antipsychotic with preferential binding to D3 receptors, was evaluated for antihostility effects in patients with schizophrenia . METHOD: Post hoc analyses were conducted using pooled data from 3 positive randomized, placebo -controlled, phase 2/3 studies in inpatients (18-60 years) with acute exacerbation of schizophrenia according to DSM-IV-TR criteria; data were collected between 2008 and 2011 . The principal post hoc outcome was mean change from baseline to week 6 on the Positive and Negative Syndrome Scale (PANSS) hostility item (P7 ); separate analyses adjusted for certain PANSS positive symptoms and sedation covariates. Analyses were based on the pooled intent-to-treat population (N = 1,466) using a mixed-effects model for repeated measures approach; separate analyses were conducted in subgroups categorized by baseline hostility item scores (P7: ≥ 2, ≥ 3, ≥ 4). RESULTS: The least squares mean difference (LSMD) in change from baseline to week 6 was statistically significant on all PANSS hostility item analyses in favor of cariprazine versus placebo : unadjusted (-0.28; P < .0001), adjusted for PANSS positive symptoms (-0.12; P < .05), adjusted for positive symptoms plus sedation (-0.12; P < .05). The magnitude of change for cariprazine increased with greater baseline hostility (LSMD vs placebo for ≥ 2, ≥ 3, ≥ 4 subgroups: -0.32, -0.37, -0.51, respectively; P < .01 all). CONCLUSIONS: Significant improvement on the hostility item was seen in cariprazine - versus placebo -treated patients with schizophrenia ; the effect of cariprazine increased with greater levels of baseline hostility . TRIALS REGISTRATION: ClinicalTrials.gov identifiers: NCT00694707, NCT01104766, and NCT01104779. © Copyright 2016 Physicians Postgraduate Press, Inc.
RCT Entities: Population
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OBJECTIVE: Although most patients with schizophrenia are not aggressive, individuals with the disorder have increased risk of hostile behavior. Cariprazine , a dopamine D3 and D2 receptor partial agonist antipsychotic with preferential binding to D3 receptors, was evaluated for antihostility effects in patients with schizophrenia . METHOD: Post hoc analyses were conducted using pooled data from 3 positive randomized, placebo-controlled, phase 2/3 studies in inpatients (18-60 years) with acute exacerbation of schizophrenia according to DSM-IV-TR criteria; data were collected between 2008 and 2011. The principal post hoc outcome was mean change from baseline to week 6 on the Positive and Negative Syndrome Scale (PANSS) hostility item (P7); separate analyses adjusted for certain PANSS positive symptoms and sedation covariates. Analyses were based on the pooled intent-to-treat population (N = 1,466) using a mixed-effects model for repeated measures approach; separate analyses were conducted in subgroups categorized by baseline hostility item scores (P7: ≥ 2, ≥ 3, ≥ 4). RESULTS: The least squares mean difference (LSMD) in change from baseline to week 6 was statistically significant on all PANSS hostility item analyses in favor of cariprazine versus placebo: unadjusted (-0.28; P < .0001), adjusted for PANSS positive symptoms (-0.12; P < .05), adjusted for positive symptoms plus sedation (-0.12; P < .05). The magnitude of change for cariprazine increased with greater baseline hostility (LSMD vs placebo for ≥ 2, ≥ 3, ≥ 4 subgroups: -0.32, -0.37, -0.51, respectively; P < .01 all). CONCLUSIONS: Significant improvement on the hostility item was seen in cariprazine - versus placebo-treated patients with schizophrenia ; the effect of cariprazine increased with greater levels of baseline hostility. TRIALS REGISTRATION: ClinicalTrials.gov identifiers: NCT00694707, NCT01104766, and NCT01104779. © Copyright 2016 Physicians Postgraduate Press, Inc.
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Year: 2016
PMID： 26845266 DOI： 10.4088/JCP.15m10192
Source DB: PubMed Journal: J Clin Psychiatry ISSN： 0160-6689 Impact factor: 4.384