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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00255515
First Posted: November 21, 2005
Last Update Posted: March 25, 2009
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 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
Schizophrenia Drug: Quetiapine fumarate Drug: conventional treatment for schizophrenia Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
oral
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
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 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT00255515


Locations
Sweden
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
AstraZeneca
Investigators
Principal Investigator: Leif Lindström, Västerås
  More Information

Responsible Party: Birgit Ekholm, MD, Neuroscience, AstraZeneca Sweden
ClinicalTrials.gov Identifier: NCT00255515     History of Changes
Other Study ID Numbers: D1449L00004
SCORE
First Submitted: November 17, 2005
First Posted: November 21, 2005
Last Update Posted: March 25, 2009
Last Verified: March 2009

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