Back to resultsSeroquel® Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia (SCORE)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Quetiapine fumarate
conventional treatment for schizophrenia
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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.
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
1
2
3
Arm Description
quetiapine fumarate
Conventional treatment for schizophrenia
quetiapine fumarate + Cognitive Remediation Therapy
Outcomes
Primary Outcome Measures
Social outcome measured by Strauss-Carpenter scale
Secondary Outcome Measures
Change in PANSS total score
Change in PANSS positive, negative and general psychopathology symptom subscales
Change in cognition as measured by a Cognitive Battery of Tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00255515
Brief Title
Seroquel® Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia
Acronym
SCORE
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
quetiapine fumarate
Arm Title
2
Arm Type
Active Comparator
Arm Description
Conventional treatment for schizophrenia
Arm Title
3
Arm Type
Experimental
Arm Description
quetiapine fumarate + Cognitive Remediation Therapy
Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate
Other Intervention Name(s)
Seroquel
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
conventional treatment for schizophrenia
Intervention Description
various standard therapies
Primary Outcome Measure Information:
Title
Social outcome measured by Strauss-Carpenter scale
Time Frame
change from baseline to last visit and end of CRT
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leif Lindström,
Organizational Affiliation
Västerås
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Eskilstuna
Country
Sweden
Facility Name
Research Site
City
Göteborg
Country
Sweden
Facility Name
Research Site
City
Hisingsbacka
Country
Sweden
Facility Name
Research Site
City
Huddinge
Country
Sweden
Facility Name
Research Site
City
Jönköping
Country
Sweden
Facility Name
Research Site
City
Lidingö
Country
Sweden
Facility Name
Research Site
City
Limhamn
Country
Sweden
Facility Name
Research Site
City
Lund
Country
Sweden
Facility Name
Research Site
City
Malmö
Country
Sweden
Facility Name
Research Site
City
Norsborg
Country
Sweden
Facility Name
Research Site
City
Nyköping
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Trollhättan
Country
Sweden
Facility Name
Research Site
City
Umeå
Country
Sweden
Facility Name
Research Site
City
Vasteras
Country
Sweden
12. IPD Sharing Statement
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Seroquel® Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia
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