Seroquel® Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia (SCORE)

March 24, 2009 updated by: AstraZeneca

An Open, Randomised, Parallel, Three Treatment Groups, Multicentre, Phase IV Study - in Real Life - to Compare the Change in Social Outcome of Quetiapine Fumarate (Seroquel®) Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia.

The purpose of this study is to compare efficacy of quetiapine fumarate combined with Cognitive Remediation Therapy (CRT) to conventional treatment by evaluating change in social outcome in patients with schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 4

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

  • Sweden
      • Eskilstuna, Sweden
        • Research Site
      • Göteborg, Sweden
        • Research Site
      • Hisingsbacka, Sweden
        • Research Site
      • Huddinge, Sweden
        • Research Site
      • Jönköping, Sweden
        • Research Site
      • Lidingö, Sweden
        • Research Site
      • Limhamn, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Malmö, Sweden
        • Research Site
      • Norsborg, Sweden
        • Research Site
      • Nyköping, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Trollhättan, Sweden
        • Research Site
      • Umeå, Sweden
        • Research Site
      • Vasteras, Sweden
        • 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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • Documented clinical diagnosis of schizophrenia or schizoaffective disorder for at least 2 years.
  • Clinically stable and in an outpatient setting before entering the study (visit 1).

Exclusion Criteria:

  • Use of clozapine and quetiapine within two months prior to visit 1.
  • If total points are ≤ 55 Intelligence quotient (IQ) according to score of WAIS-III test at visit 1.

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
quetiapine fumarate
Drug: Quetiapine fumarate
oral
Other Names:
  • Seroquel
Active Comparator: 2
Conventional treatment for schizophrenia
Drug: conventional treatment for schizophrenia
various standard therapies
Experimental: 3
quetiapine fumarate + Cognitive Remediation Therapy
Drug: Quetiapine fumarate
oral
Other Names:
  • Seroquel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Social outcome measured by Strauss-Carpenter scale
Time Frame: change from baseline to last visit and end of CRT
change from baseline to last visit and end of CRT

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in PANSS total score
Time Frame: change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit
change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit
Change in PANSS positive, negative and general psychopathology symptom subscales
Time Frame: change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit
change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit
Change in cognition as measured by a Cognitive Battery of Tests
Time Frame: change from baseline to end of CRT and from baseline to last visit
change from baseline to end of CRT and from baseline to last visit

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Leif Lindström,, Västerås

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

September 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 17, 2005

First Submitted That Met QC Criteria

November 17, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Estimate)

March 25, 2009

Last Update Submitted That Met QC Criteria

March 24, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1449L00004
  • SCORE

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.

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