Rapid Versus Conventional Titration of Quetiapine in Schizophrenia/Schizoaffective Disorder
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorders; Psychotic Disorders
Intervention: Quetiapine IR (Immediate Release) (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca UK Medical Director, MD, Study Director, Affiliation: AstraZeneca UK
Professor Gary Sullivan, MD, Principal Investigator, Affiliation: St Tydfil's Hospital
Summary
The purpose of this study is to determine whether increasing the amount (dose) of quetiapine
IR (immediate release formulation) more rapidly than conventional dose increases, improves
the control of symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) - a psychiatric assessment scale that measures both positive and negative symptoms - in patients
with acute schizophrenia or schizoaffective disorder.
Clinical Details
Official title: RAPID-An Open-Label Randomized, Multicenter Phase IIIb Study to Evaluate the Efficacy and Tolerability of Quetiapine IR (Immediate Release), Over 14 Days, in Acute Schizophrenia/Schizoaffective Disorder (Rapid Versus Conventional Titration)
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary outcome variable of this study is change from baseline in total PANSS score
Secondary outcome: Change from baseline in total PANSS scoreschange from baseline in CGI-S and absolute CGI-I frequency and severity of adverse events; change in vital signs. change from baseline in subscale PANSS and PANSS-EC scores
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Men and women, aged 18 to 65 years, who require treatment for an acute episode of
schizophrenia/schizoaffective disorder as judged by their doctor
Exclusion Criteria:
- Significant and unstable conditions of hear, circulation, blood, liver, kidney;
malignancies (cancer); diabetes (mellitus); history of fits or fainting. Resistance
to antipsychotic medication. Current alcohol/drug abuse. Pregnant/breast feeding
women.
Locations and Contacts
Research Site, Birmingham, United Kingdom
Research Site, Bognor Regis, United Kingdom
Research Site, Bury St Edmunds, United Kingdom
Research Site, Coventry, United Kingdom
Research Site, Crewe, United Kingdom
Research Site, Darlington, United Kingdom
Research Site, London, United Kingdom
Research Site, Sandbach, United Kingdom
Research Site, Warrington, United Kingdom
Research Site, Brentwood, Essex, United Kingdom
Research Site, Harrow, Middlesex, United Kingdom
Research Site, Surbiton, Surrey, United Kingdom
Additional Information
AstraZeneca Clinical Trial Information - Outside US
Starting date: July 2007
Ending date: September 2007
Last updated: November 26, 2007
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