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ISSN: 1935-1232 (P)

ISSN: 1941-2010 (E)

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Abstract

Management of Depressive Symptoms in Schizophrenia: A Pooled, Post Hoc Analysis From the Asenapine Development Program

Author(s): David J. Castle, Jens-Kristian Slott Jensen

Background: Although depressive symptoms are a frequently occurring phenomenon in schizophrenia, effective treatments remain an area of clinical need. Objective: To assess the benefit of short-term treatment with the atypical antipsychotic asenapine versus placebo on depressive symptoms in patients with acute schizophrenia in an exacerbated state. Methods: Data were pooled from intent-to-treat (ITT) populations of three 6-week, randomized controlled studies with fixed doses of asenapine (ASE; n=427), olanzapine (OLA; n=82), risperidone (RIS; n=54), haloperidol (HAL; n=97), or placebo (PLA; n=254). Change from baseline Calgary Depression Scale for Schizophrenia (CDSS) total score and individual item scores were assessed at Day 21 and Day 42 in the total patient population (n=914), and in patients presenting with a CDSS total score of ≥6 at baseline (n=248). Mixed model repeated measures (MMRM) analyses were performed on patient data. Results: The observed change from baseline in CDSS total score was significantly larger with ASE—compared to PLA—at both Day 21 (p<0.05) and Day 42 (p<0.01) for the total patient population group, and at Day 21 (p<0.05) in patients with baseline CDSS total score ≥6. For both populations, there was a significant change from baseline in the CDSS depression item score with ASE—compared to PLA—at Day 21 (p<0.01, all patient population; p<0.05, patients with baseline CDSS ≥6), and at Day 42 (p<0.01) in the all patient population. Statistically significant changes from baseline, in favor of ASE versus PLA, were also observed in other individual CDSS item scores including hopelessness (p<0.05, Day 21, patients with baseline CDSS ≥6), self-depreciation (p<0.05, Day 42, all patient population), guilty ideas of reference (p<0.01, Day 42, all patient population), pathological guilt (p<0.01, Day 21, all patient population; p<0.05, Day 21 and Day 42, patients with baseline CDSS score ≥6), and observed depression (p<0.05, Day 21, all patient population). Conclusions: ASE significantly improved a range of depressive symptoms in people with an acute exacerbation of schizophrenia, as measured by the CDSS. ASE may represent a beneficial treatment option for the management of depressive symptoms in patients with schizophrenia.