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Rapid Versus Conventional Titration of Quetiapine in Schizophrenia/Schizoaffective Disorder (RAPID)

This study has been terminated.
(Study terminated due to poor recruitment)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00457899
First received: April 5, 2007
Last updated: November 26, 2007
Last verified: November 2007
History of Changes

April 5, 2007
November 26, 2007
July 2007
Not Provided
The primary outcome variable of this study is change from baseline in total PANSS score [ Time Frame: at Day 7 ]
The primary outcome variable of this study is change from baseline in total PANSS score at Day 7
Complete list of historical versions of study NCT00457899 on ClinicalTrials.gov Archive Site
  • Change from baseline in total PANSS scores [ Time Frame: on day 5 and 14 ]
  • change from baseline in CGI-S and absolute CGI-I [ Time Frame: on days 5, 7 and 14 ]
  • frequency and severity of adverse events; change in vital signs. [ Time Frame: assessed at each visit ]
  • change from baseline in subscale PANSS and PANSS-EC scores [ Time Frame: on days 5, 7 and 14 ]
Change from baseline in total PANSS scores on day 5 and 14, subscale PANSS and PANSS-EC scores on days 5, 7 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.
Not Provided
Not Provided
 
Rapid Versus Conventional Titration of Quetiapine in Schizophrenia/Schizoaffective Disorder
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorders
  • Psychotic Disorders
Drug: Quetiapine IR (Immediate Release)
oral
Other Name: Seroquel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
234
September 2007
Not Provided

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00457899
D1443L00003
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca UK Medical Director, MD AstraZeneca UK
Principal Investigator: Professor Gary Sullivan, MD St Tydfil's Hospital
AstraZeneca
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP