Status:
TERMINATED
Seroquel XR in Adults With Schizophrenia
Lead Sponsor:
AstraZeneca
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy of Seroquel XR in schizophrenia patients with acute worsening symptoms. Consequently, to assess whether the study drug is safe and acceptable on t...
Eligibility Criteria
Inclusion
- Patient meets the DSM-IV criteria for schizophrenia
- Patient has a PANSS total score ≥ 70 at baseline
- Patient has a CGI-S score of ≥ 4(moderately ill) at baseline
- Patient is healthy on the basis of physical examination and vital signs at baseline
Exclusion
- Positive urine drug screen for Opiates, amphetamine, barbiturate, cocaine, cannabis, or ecstasy abuse
- Has history of neuroleptic malignant syndrome, seropositive for anti-HIV, hepatitis B or C virus antigen
- Patient with unstable or inadequately treated Diabetes Mellitus
- Use of potent cytochrome P450 inhibitors or inducer within 14 days before baseline
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00852631
Start Date
February 1 2009
End Date
May 1 2010
Last Update
July 17 2012
Active Locations (3)
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1
Research Site
Bangkok, Thailand
2
Research Site
Chiang Mai, Thailand
3
Research Site
Songkhla, Thailand