Schizophrenia is a chronic psychiatric disorder that often begins during adolescence or early adulthood. A major problem for patients with schizophrenia is a cognitive deficit compared to a control group of healthy. It is generally accepted that a patient’s cognitive ability is closely correlated with clinical outcome. It can be concluded that patients have very poor cognition in acute psychotic episodes depending on treatment with high doses of antipsychotic drugs.
Conditions
Interventions
Product Name: Seroquel
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: quetiapine fumarate
Concentration unit: mg milligram(s)
Concentration number: 25, 100, 200, 300-
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent before initiation of any study-related procedures. 2. Female and male aged 18 to 64. 3. Documented clinical diagnosis of schizophrenia or schizoaffective disorder (295.10, 295.20, 295.30, 295.60, 295.70, 295.90) for at least 2 years, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). 4. Clinically stable and in an outpatient setting before entering the study (visit 1), treatment with antipsychotic agent(s), ATC code NO5A, (quetiapine and clozapine not allowed within two months prior to visit 1). 5. Female patients of childbearing potential must have a negative pregnancy test at enrolment and use a reliable method of birth control as judged by the Investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Use of clozapine or quetiapine within two months prior to visit 1. 2. Deleted 3. Deleted 4. History of known non-responsiveness to clozapine and quetiapine. 5. Contraindications as detailed in the Summary of Product Characteristics for quetiapine. 6. Use of drugs suspected to affect the liver drug-metabolising enzymes especially cytochrome P450 3A4 inhibitors or inducers within 2 weeks prior to enrolment (e.g.: ketoconazole (except for topical use), erythromycin, carbamazepin, thioridazine, phenytoin, St. Johns Wort, and barbiturates. 7. Patients with a history of non-compliance as judged by the Investigator. 8. Female patients who are pregnant, lactating or at risk of pregnancy. 9. Diagnosis of any other DSM-IV Axis I disorder other than those included in inclusion criteria 3 above (e.g. alcohol dependence or psychoactive substance dependence not in full remission) or mental retardation [axis II diagnosis] of a degree that may interfere with the patient’s ability to co-operate. 10. If total points are = 55 Intelligence quotient (IQ) according to score of WAIS-III test at visit 1. 11. Inability to read and/or understand Swedish. 12. Evidence of clinically relevant disease, (e.g., serious head-injury, advanced cancer, liver, renal or heart disease or risk of transmitting Human Immunodeficiency Virus (HIV), hepatitis B and C) or other unstable condition in the opinion of the Investigator. 13. Previous cognitive treatment aiming at improving the patient’s neurocognitive capacity within three years prior to visit 1. 14. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site). 15. Previous enrolment or randomisation of treatment in the present study. Exclusion criteria at visit 2 1. An increase in the PANSS total score more than or equal to 20% from baseline (visit 1) to visit 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare efficacy of quetiapine fumarate (hereafter called quetiapine) combined with Cognitive Remediation Therapy (CRT) to conventional treatment by evaluating change in social outcome, from baseline (visit 1) to the end of CRT (visit 3), in patients with schizophrenia, assessed by Strauss-Carpenter scale.;Secondary Objective: 1. to compare efficacy of quetiapine (SQL) combined with CRT to conventional treatment (CvT) by evaluating change in social outcome in patients with schizophrenia assessed by Strauss-Carpenter scale, from baseline to last visit. Analyses of change from baseline to end of CRT and from baseline to last visit: 2. to compare change in patient’s overall clinical status when using SQL combined with CRT to CvT assessed by PANSS. 3. to compare change in Quality of Life of SQL combined with CRT to CvT assessed by SF-36 and DAI-10. 4. to compare change in cognition when using SQL combined with CRT to CvT assessed by a Cognitive Battery of Tests. 5. to compare the safety parameter of SQL combined with CRT to CvT by evaluating: the Simpson-Angus Scale (SAS), BARS, vital signs including clinical chemistry and BMI (only changes from baseline to the last visit). Analyses of change from baseline to visit 2: 6. to compare SQL to CvT assessed by the change in PANSS, SF-36, DAI-10, SAS and BARS. ;Primary end point(s): This study will use social functioning measured by the Strauss-Carpenter scale as primary endpoint. It covers four robust domains (time in hospital, employment, social contacts and psychotic symptoms). Changes in Strauss-Carpenter scale are very important measuring the social status in a patient life and an improvement will be of clinical value. | — |
Countries
Sweden
Outcome results
None listed