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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: November 17, 2005
Last updated: March 24, 2009
Last verified: March 2009
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.

Condition Intervention Phase
Drug: Quetiapine fumarate
Drug: conventional treatment for schizophrenia
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Social outcome measured by Strauss-Carpenter scale [ Time Frame: change from baseline to last visit and end of CRT ]

Secondary Outcome Measures:
  • 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 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 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 ]

Enrollment: 85
Study Start Date: September 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
quetiapine fumarate
Drug: Quetiapine fumarate
Other Name: 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
Other Name: Seroquel


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00255515

Research Site
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
Sponsors and Collaborators
Principal Investigator: Leif Lindström, Västerås
  More Information

Responsible Party: Birgit Ekholm, MD, Neuroscience, AstraZeneca Sweden Identifier: NCT00255515     History of Changes
Other Study ID Numbers: D1449L00004
Study First Received: November 17, 2005
Last Updated: March 24, 2009

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on April 28, 2017