Back to resultsRapid Versus Conventional Titration of Quetiapine in Schizophrenia/Schizoaffective Disorder (RAPID)
Primary Purpose
Schizophrenia, Schizoaffective Disorders, Psychotic Disorders
Status
Terminated
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Quetiapine IR (Immediate Release)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, schizoaffective disorder, quetiapine, seroquel, titration
Eligibility 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.
Sites / Locations
- Research Site
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Outcomes
Primary Outcome Measures
The primary outcome variable of this study is change from baseline in total PANSS score
Secondary Outcome Measures
Change from baseline in total PANSS scores
change 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00457899
Brief Title
Rapid Versus Conventional Titration of Quetiapine in Schizophrenia/Schizoaffective Disorder
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to poor recruitment
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorders, Psychotic Disorders
Keywords
schizophrenia, schizoaffective disorder, quetiapine, seroquel, titration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
234 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine IR (Immediate Release)
Other Intervention Name(s)
Seroquel
Intervention Description
oral
Primary Outcome Measure Information:
Title
The primary outcome variable of this study is change from baseline in total PANSS score
Time Frame
at Day 7
Secondary Outcome Measure Information:
Title
Change from baseline in total PANSS scores
Time Frame
on day 5 and 14
Title
change from baseline in CGI-S and absolute CGI-I
Time Frame
on days 5, 7 and 14
Title
frequency and severity of adverse events; change in vital signs.
Time Frame
assessed at each visit
Title
change from baseline in subscale PANSS and PANSS-EC scores
Time Frame
on days 5, 7 and 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca UK Medical Director, MD
Organizational Affiliation
AstraZeneca UK
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Professor Gary Sullivan, MD
Organizational Affiliation
St Tydfil's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Brentwood
State/Province
Essex
Country
United Kingdom
Facility Name
Research Site
City
Harrow
State/Province
Middlesex
Country
United Kingdom
Facility Name
Research Site
City
Surbiton
State/Province
Surrey
Country
United Kingdom
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
Bognor Regis
Country
United Kingdom
Facility Name
Research Site
City
Bury St Edmunds
Country
United Kingdom
Facility Name
Research Site
City
Coventry
Country
United Kingdom
Facility Name
Research Site
City
Crewe
Country
United Kingdom
Facility Name
Research Site
City
Darlington
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Sandbach
Country
United Kingdom
Facility Name
Research Site
City
Warrington
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Rapid Versus Conventional Titration of Quetiapine in Schizophrenia/Schizoaffective Disorder
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