Study identifier:D1443L00031
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Comparison of Quetiapine Extended-Release (Seroquel XR™) and Risperidone in the treatment of depressive symptoms, in schizophrenic or schizoaffective patients: A randomized, open label, flexible-dose, parallel group, non inferiority, 12-week study
schizophrenia
Phase 3
No
Quetiapine Extended Release, Risperidone
All
216
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 May 2012 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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.
Location
Location
FERMO, AP, Italy
Location
BERGAMO, BG, Italy
Location
BRINDISI, BR, Italy
Location
CARBONIA, CA, Italy
Location
TERMOLI, CB, Italy
Location
CATANIA, CT, Italy
Location
NICOSIA, EN, Italy
Location
LIDO DI CAMAIORE, LU, Italy
Arms | Assigned Interventions |
---|---|
Experimental: Quetiapine Extended Release | Drug: Quetiapine Extended Release Uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day Other Name: Seroquel XR™ |
Active Comparator: Risperidone | Drug: Risperidone Uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient. Other Name: Risperdal |
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