OBSERVA | C4C

Asenapine is a novel atypical antipsychotic agent, developed for the treatment of moderate to severe manic episodes associated with bipolar I disorder and schizophrenia in adults. To date, the clinical trial safety data for asenapine in patients with schizophrenia or bipolar I disorder is based on 3457 patients, of which 631 patients are classified as having bipolar I disorder in phase 2/3 clinical trials. In total, 350 patients are recorded as having been exposed for more than 12 months, with 16 classified as having bipolar I disorder. Additional information from larger numbers outside the clinical trial setting, in conditions of routine clinical practice, may be helpful to further monitor possible adverse events in users of asenapine. This study will enable the systematic collection and reporting of safety data on patients newly initiated on treatment with asenapine, with a particular focus on obtaining information on patients who stop taking asenapine prior to transfer of care to their GP. Its purpose will be to provide information on a large number of such patients and the treatment they received in a mental health care trust clinical practice setting.