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NCT00457899 Clinical Trial

Rapid Versus Conventional Titration of Quetiapine in Schizophrenia/Schizoaffective Disorder

Schizophrenia Clinical Trial

— RAPID  

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)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00457899
Other study ID # D1443L00003
Secondary ID
Status Terminated
Phase Phase 3
First received April 5, 2007
Last updated November 26, 2007
Start date July 2007
Est. completion date September 2007

Study information
Verified date November 2007
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Quetiapine IR (Immediate Release)
oral

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome
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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