Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic
The primary objective of the study is to evaluate the efficacy of quetiapine fumarate (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline in PANSS total score at Day 56 using the last observation carried forward (LOCF) method...
Brief Summary
Official Title: “A 24-Week, Multi-Centre, Open-Label, Single-Arm, Phase IV Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) With Daily Dose 600mg-750mg as Mono-Therapy in the Treatment of Acute Schizophrenic Patients”
The primary objective of the study is to evaluate the efficacy of quetiapine fumarate (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline in PANSS total score at Day 56 using the last observation carried forward (LOCF) method.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: September 2007
Intervention(s) in this Clinical Trial
- Drug: Quetiapine Fumarate (Seroquel)
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline in PANSS total score at Day 56 (LOCF)
Secondary Measures
- Change from baseline in PANSS positive scale score at Day 56 (LOCF)
- Change from baseline in PANSS negative scale score at Day 56 (LOCF)
- Change from baseline in PANSS EC score at day 56 ,
- Change from baseline in MADRS total score at Day 56. etc
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Provision of written informed consent for study participation before initiation of any study related procedures, signed by the patient's legal guardian
- Female and/or male, aged between 18 and 60 years (inclusive)
- Is hospitalised in a psychiatric unit with an acute episode of schizophrenia defined by CCMD-3 criteria as one of the following: [20.1] paranoid schizophrenia, [20.2] hebephrenic schizophrenia, [20.3] catatonic schizophrenia, [20.5] undifferentiated schizophrenia
Exclusion Criteria:
- CCMD-3 diagnosis of mental retardation
- Psychosis judged to be the direct physiological effect of an abused medication or substance
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 60 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Jon Zhu, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00428350
Study ID Number: D1443L00004
ClinicalTrials.gov Identifier: NCT00428350
Health Authority: China: State Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00428350
