Seroquel® Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia
SCORE
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.
2 other identifiers
interventional
85
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 schizophrenia
Started Sep 2005
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 17, 2005
CompletedFirst Posted
Study publicly available on registry
November 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedMarch 25, 2009
March 1, 2009
2.2 years
November 17, 2005
March 24, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Social outcome measured by Strauss-Carpenter scale
change from baseline to last visit and end of CRT
Secondary Outcomes (3)
Change in PANSS total score
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
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
change from baseline to end of CRT and from baseline to last visit
Study Arms (3)
1
EXPERIMENTALquetiapine fumarate
2
ACTIVE COMPARATORConventional treatment for schizophrenia
3
EXPERIMENTALquetiapine fumarate + Cognitive Remediation Therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (15)
Research Site
Eskilstuna, Sweden
Research Site
Gothenburg, 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
Malmo, Sweden
Research Site
Norsborg, Sweden
Research Site
Nyköping, Sweden
Research Site
Stockholm, Sweden
Research Site
Trollhättan, Sweden
Research Site
Umeå, Sweden
Research Site
Västerås, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leif Lindström,
Västerås
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 17, 2005
First Posted
November 21, 2005
Study Start
September 1, 2005
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
March 25, 2009
Record last verified: 2009-03