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

Schizophrenia Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255515
• Other study ID #: D1449L00004
• Secondary ID: SCORE
• Status: Completed
• Phase: Phase 4
• First received: November 17, 2005
• Last updated: March 24, 2009
• Start date: September 2005
• Est. completion date: December 2007

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Quetiapine fumarate
oral
• conventional treatment for schizophrenia
various standard therapies

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social outcome measured by Strauss-Carpenter scale		change from baseline to last visit and end of CRT	No
Secondary	Change in PANSS total score		change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit	No
Secondary	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	No
Secondary	Change in cognition as measured by a Cognitive Battery of Tests		change from baseline to end of CRT and from baseline to last visit	No