Status:
COMPLETED
Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)
Lead Sponsor:
AstraZeneca
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 schiz...
Eligibility Criteria
Inclusion
- Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
- PANSS total score of at least 70 at enrolment and at assignment Day 1
- CGI Severity of Illness score of at least 4 (moderately ill) at enrolment and at assignment Day 1 and with worsening of the patient's condition during the 3 weeks
Exclusion
- Known intolerance or lack of response to quetiapine fumarate
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before assignment
- Substance or alcohol dependence at enrolment
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00779506
Start Date
November 1 2008
End Date
July 1 2009
Last Update
November 23 2011
Active Locations (7)
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1
Research site
Ansan, Gyeonggi-do, South Korea
2
Research site
Gwangju, Gyeonggi-do, South Korea
3
Research site
Bugok, Gyeongsangnam-do, South Korea
4
Research site
Masan, Gyeongsangnam-do, South Korea