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Extended-release quetiapine fumarate (quetiapine XR) versus risperidone in the treatment of depressive symptoms in patients with schizoaffective disorder or schizophrenia: a randomized, open-label, parallel-group, flexible-dose study

Di Fiorino, Marioa; Montagnani, Ginob; Trespi, Graziellab; Kasper, Siegfriedc

International Clinical Psychopharmacology: May 2014 - Volume 29 - Issue 3 - p 166–176
doi: 10.1097/YIC.0000000000000017
Original Articles

Depressive symptoms are associated with poor outcomes, increased risk of relapse, and high suicide rates in patients with schizophrenia and schizoaffective disorder. This randomized, open-label, parallel-group, flexible-dose study (NCT00640562) assessed the efficacy of quetiapine extended release (XR) versus risperidone on depressive symptoms in this patient population. Noninferiority of quetiapine XR versus risperidone from baseline to week 12 was assessed by least squares mean (LSM) reduction in the Calgary Depression Scale for Schizophrenia (CDSS). Noninferiority was indicated if the difference in CDSS reductions between quetiapine XR and risperidone had a 95% confidence interval (CI) lower limit of more than −2.7. Overall, 216 patients received quetiapine XR (n=109; 400–800 mg/day) or risperidone (n=107; 4–6 mg/day). In the per-protocol population, LSM CDSS reductions for quetiapine XR and risperidone were 8.4 and 6.2 points, respectively (95% CI 0.8–3.7). As the lower limit of the 95% CI was more than −2.7 and the LSM reduction for quetiapine XR was 2.2 points higher than that for risperidone, noninferiority of quetiapine XR versus risperidone was demonstrated. Adverse events for quetiapine XR and risperidone were comparable. In this study, quetiapine XR was noninferior to risperidone at reducing depressive symptoms in patients with schizophrenia or schizoaffective disorder.

aDepartment of Psychiatry, Versilia Hospital, Lido di Camaiore

bAstraZeneca, Research & Development, Milan, Italy

cDepartment of Psychiatry and Psychotherapy, Medical University, Vienna, Austria

Correspondence to Siegfried Kasper, MD, Department of Psychiatry and Psychotherapy, Medical University of Vienna, AKH, Währinger Gürtel 18-20, A-1090 Vienna, Austria Tel: +43 1 40400 3568; fax: +43 1 40400 3099; e-mail: biol-psychiatry@meduniwien.ac.at

Received October 2, 2013

Accepted October 12, 2013

© 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins