drugset / Trial / NCT00640562
Quetiapine Extended Release Depression Symptoms
RandomizedParallel-groupOpen-labelTreatment
Summary
Aim of the study is to assess if the new compound Seroquel XR™ is non-inferior to Risperidone, considered as the reference drug for the treatment of depressive symptoms of schizophrenia. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Timeline
- Start
- 2008-02
- Primary completion
- 2010-02
- Completion
- 2010-02
Publications
- Kasper S, Montagnani G, Trespi G, Di Fiorino M. Treatment of depressive symptoms in patients with schizophrenia: a randomized, open-label, parallel-group, flexible-dose subgroup analysis of patients treated with extended-release quetiapine fumarate or risperidone. Int Clin Psychopharmacol. 2015 Jan;30(1):14-22. doi: 10.1097/YIC.0000000000000053.
- Di Fiorino M, Montagnani G, Trespi G, Kasper S. 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. Int Clin Psychopharmacol. 2014 May;29(3):166-76. doi: 10.1097/YIC.0000000000000017.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Quetiapine | Small molecule | 400 mg | — |
| Subject | Quetiapine | Small molecule | 800 mg | — |
| Comparator | Risperidone | Other / unclassified | 4 mg | — |
| Comparator | Risperidone | Other / unclassified | 6 mg | — |