Study Stopped
Study terminated due to poor recruitment
Rapid Versus Conventional Titration of Quetiapine in Schizophrenia/Schizoaffective Disorder
RAPID
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)
1 other identifier
interventional
234
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
Started Jul 2007
Shorter than P25 for phase_3 schizophrenia
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2007
CompletedFirst Posted
Study publicly available on registry
April 9, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedNovember 27, 2007
November 1, 2007
April 5, 2007
November 26, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome variable of this study is change from baseline in total PANSS score
at Day 7
Secondary Outcomes (4)
Change from baseline in total PANSS scores
on day 5 and 14
change from baseline in CGI-S and absolute CGI-I
on days 5, 7 and 14
frequency and severity of adverse events; change in vital signs.
assessed at each visit
change from baseline in subscale PANSS and PANSS-EC scores
on days 5, 7 and 14
Interventions
Eligibility Criteria
You may qualify if:
- Men and women, aged 18 to 65 years, who require treatment for an acute episode of schizophrenia/schizoaffective disorder as judged by their doctor
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (12)
Research Site
Brentwood, Essex, United Kingdom
Research Site
Harrow, Middlesex, United Kingdom
Research Site
Surbiton, Surrey, United Kingdom
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca UK Medical Director, MD
AstraZeneca UK
- PRINCIPAL INVESTIGATOR
Professor Gary Sullivan, MD
St Tydfil's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 5, 2007
First Posted
April 9, 2007
Study Start
July 1, 2007
Study Completion
September 1, 2007
Last Updated
November 27, 2007
Record last verified: 2007-11