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A Phase IV Prospective, Double-blind, Double-dummy, Randomised, Crossover Study to Assess the Impact on Daily Cognitive Functioning of Quetiapine Fumarate Immediate Release (Seroquel IR®) Dosed Twice Daily and Quetiapine Fumarate Extended Release (Seroquel XR®) Dosed Once Daily in the Evening in Patients With Stable Schizophrenia (eXtRa)
This will be a phase IV 20 -32 day prospective, double blind, double-dummy, randomised crossover study that will evaluate the effect of quetiapine XR and quetiapine IR on cognitive performance in patients with schizophrenia stabilized on a single antipsychotic medication.
Details
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 75 |
| Start date | 2010-11 |
| Completion | 2011-08 |
Conditions
- Schizophrenia
Interventions
- Seroquel XR- quetiapine fumarate extended release
- Seroquel IR - quetiapine fumarate
- Placebo matching Seroquel XR
- Placebo matching Seroquel IR
Primary outcomes
- Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance) — Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.
Attentional standardised composite score: Standardised speed of performance score. Higher Score=better performance. Score range minus infinity to plus infinity. Measured at baseline (before study drug administration) and in Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. (Last test day not earlier than after 10 days of randomised)and in Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Last test day not earlier than after 10 days of crossover treatment.
Countries
Austria, Denmark, Germany, Italy, Spain