Schizophrenia
Conditions
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.
Interventions
DRUGQuetiapine fumarate
oral
DRUGconventional treatment for schizophrenia
various standard therapies
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Social outcome measured by Strauss-Carpenter scale | change from baseline to last visit and end of CRT |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Sweden
Outcome results
None listed