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

November 26, 2007 updated by: AstraZeneca

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

234

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • 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
        • Research Site
    • Essex
      • Brentwood, Essex, United Kingdom
        • Research Site
    • Middlesex
      • Harrow, Middlesex, United Kingdom
        • Research Site
    • Surrey
      • Surbiton, Surrey, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome variable of this study is change from baseline in total PANSS score
Time Frame: at Day 7
at Day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in total PANSS scores
Time Frame: on day 5 and 14
on day 5 and 14
change from baseline in CGI-S and absolute CGI-I
Time Frame: on days 5, 7 and 14
on days 5, 7 and 14
frequency and severity of adverse events; change in vital signs.
Time Frame: assessed at each visit
assessed at each visit
change from baseline in subscale PANSS and PANSS-EC scores
Time Frame: on days 5, 7 and 14
on days 5, 7 and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca UK Medical Director, MD, AstraZeneca UK
  • Principal Investigator: Professor Gary Sullivan, MD, St Tydfil's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

April 5, 2007

First Submitted That Met QC Criteria

April 5, 2007

First Posted (Estimate)

April 9, 2007

Study Record Updates

Last Update Posted (Estimate)

November 27, 2007

Last Update Submitted That Met QC Criteria

November 26, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1443L00003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psychotic Disorders

Clinical Trials on Quetiapine IR (Immediate Release)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe