Schizophrenia Clinical Trial
— RAPIDOfficial 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)
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.
Status | Terminated |
Enrollment | 234 |
Est. completion date | September 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Research Site | Birmingham | |
United Kingdom | Research Site | Bognor Regis | |
United Kingdom | Research Site | Brentwood | Essex |
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 | Harrow | Middlesex |
United Kingdom | Research Site | London | |
United Kingdom | Research Site | Sandbach | |
United Kingdom | Research Site | Surbiton | Surrey |
United Kingdom | Research Site | Warrington |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome variable of this study is change from baseline in total PANSS score | at Day 7 | ||
Secondary | Change from baseline in total PANSS scores | on day 5 and 14 | ||
Secondary | change from baseline in CGI-S and absolute CGI-I | on days 5, 7 and 14 | ||
Secondary | frequency and severity of adverse events; change in vital signs. | assessed at each visit | ||
Secondary | change from baseline in subscale PANSS and PANSS-EC scores | on days 5, 7 and 14 |
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