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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 )

First Received on April 5, 2007.   Last Updated on November 26, 2007   History of Changes
Sponsor: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00457899
  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 III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Mental Disorders Psychotic Disorders Schizophrenia
Drug Information available for: Quetiapine Quetiapine fumarate
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00457899     History of Changes
Other Study ID Numbers: D1443L00003
Study First Received: April 5, 2007
Last Updated: November 26, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
schizophrenia
schizoaffective disorder
quetiapine
seroquel
titration

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012



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