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A 8-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) With Daily Dose 400mg-800mg in the Treatment of Acute Schizophrenic Patients
This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients. The eligible patient will be assigned to study treatment with Quetiapine XR on Day 1. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Research site
Ansan, Gyeonggi-do, South Korea
Research site
Gwangju, Gyeonggi-do, South Korea
Research site
Bugok, Gyeongsangnam-do, South Korea
Research site
Masan, Gyeongsangnam-do, South Korea
Research site
Incheon, South Korea
Research site
Pusan, South Korea
Research site
Seoul, South Korea
Start Date
November 1, 2008
Primary Completion Date
July 1, 2009
Completion Date
July 1, 2009
Last Updated
November 23, 2011
96
ACTUAL participants
Quetiapine Fumarate XR
DRUG
Lead Sponsor
AstraZeneca
NCT07455929
NCT06740383
Data Source & Attribution
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