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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:
ClinicalTrials.gov Identifier:
NCT00457899
First Posted: April 9, 2007
Last Update Posted: November 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Schizophrenia Schizoaffective Disorders Psychotic Disorders Drug: Quetiapine IR (Immediate Release) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The primary outcome variable of this study is change from baseline in total PANSS score [ Time Frame: at Day 7 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 234
Study Start Date: July 2007
Study Completion Date: September 2007
Intervention Details:
    Drug: Quetiapine IR (Immediate Release)
    oral
    Other Name: Seroquel
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457899


Locations
United Kingdom
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca UK Medical Director, MD AstraZeneca UK
Principal Investigator: Professor Gary Sullivan, MD St Tydfil's Hospital
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00457899     History of Changes
Other Study ID Numbers: D1443L00003
First Submitted: April 5, 2007
First Posted: April 9, 2007
Last Update Posted: November 27, 2007
Last Verified: November 2007

Keywords provided by AstraZeneca:
schizophrenia
schizoaffective disorder
quetiapine
seroquel
titration

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs