Seroquel® Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Quetiapine fumarate (Drug); conventional treatment for schizophrenia (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Martin Brecher, MD, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Social outcome measured by Strauss-Carpenter scale
Secondary outcome: Change in PANSS total scoreChange in PANSS positive, negative and general psychopathology symptom subscales Change in cognition as measured by a Cognitive Battery of Tests
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
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.
Locations and Contacts
Research Site, ESKILSTUNA, Sweden
Research Site, GÖTEBORG, Sweden
Research Site, HUDDINGE, Sweden
Research Site, JÖNKÖPING, Sweden
Research Site, LIMHAMN, Sweden
Research Site, LUND, Sweden
Research Site, MALMÖ, Sweden
Research Site, NORSBORG, Sweden
Research Site, STOCKHOLM, Sweden
Research Site, Umeå, Sweden
Research Site, Vasteras, Sweden
Research Site, Lidingö, Sweden
Research Site, Nyköping, Sweden
Research Site, Trollhättan, Sweden
Research Site, Hisingsbacka, Sweden
Additional Information
Starting date: September 2005
Ending date: December 2007
Last updated: January 25, 2008
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