Why the study?
Does cariprazine improve antipsychotic and antimanic activity in patients with schizophrenia or bipolar I disorder?
Does cariprazine improve antipsychotic and antimanic activity in patients with schizophrenia or bipolar I disorder?
Cariprazine shows superiority over placebo for schizophrenia and bipolar I disorder, though it is associated with high rates of akathisia and extrapyramidal symptoms.
May support use in schizophrenia and bipolar I; leaves open long-term safety and tolerability questions.
Cariprazine is a novel drug with partial agonist activity at dopamine D2/3 receptors and six- to eightfold higher affinity for human dopamine D3 over D2 receptors. Results from several placebo-controlled Phase II/III trials in patients with a The Diagnostic and Statistical Manual of Mental Disorders IV diagnosis of schizophrenia or bipolar I disorder suggest that cariprazine is superior to placebo with respect to antipsychotic and antimanic activity. Reports concerning safety and tolerability of cariprazine are mainly favorable, although the rates of treatment-associated adverse events, which most commonly included akathisia and extrapyramidal symptom, are rather high. However, only minor alterations of clinical laboratory values, prolactin concentrations and ECG parameters are reported in cariprazine-treated patients. A new drug application to the U.S. F DA for cariprazine for the treatment of both schizophrenia and manic or mixed episodes associated with bipolar I disorder was submitted in November 2012. A more precise assessment of the clinical properties of this new drug will require additional studies, aimed to compare and contrast cariprazine with other antipsychotic agents.
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Veselinović et al. (2013) studied this question.
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