Seroquel XR in Adults With Schizophrenia
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Quetiapine fumarate (Seroquel) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Thawatchai Leelahanaj, MD, Principal Investigator, Affiliation: Phramongkutklao Hospital, Bangkok, Thailand
Overall contact:
AstraZeneca Thainland Clinical Study Information, Phone: 66-2-7397400, Email: sasarose.rochanaruangrai@astrazeneca.com
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 the daily dose basis, orally given, up to 600 mg once a day for 42
days.
Clinical Details
Official title: Open-Label Multicentre Study on Efficacy and Safety of Oral Quetiapine (Seroquel XR) in Adults With Schizophrenia
Study design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Change in PANSS total score from baseline (day 1) to final visit (day 42)Recording of adverse events
Secondary outcome: Change in PANSS total score from baseline to each post-baseline visitChange in CGI assessment
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
AstraZeneca Thainland Clinical Study Information, Phone: 66-2-7397400, Email: sasarose.rochanaruangrai@astrazeneca.com
Research Site, Bangkok, Thailand; Recruiting
Additional Information
Starting date: February 2009
Ending date: March 2010
Last updated: February 26, 2009
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