Patients with schizophrenia, who are not in an acute state of psychosis at enrolment (PANSS score < 80) and who do not show criteria of moderate depression, but may show depression-like symptoms corresponding to negative symptoms of schizophrenia (MADRS score =XXX). ICD classification code : F 20.0, 20.1, 20.2, 20.3, 20.5, 20.6
Conditions
Interventions
Trade Name: Seroquel®
Product Name: Seroquel®
Product Code: 47291.00.00
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Quetiapine
Current Sponsor code: QUETIAPINKOGNSCHIZOPHR
Concentrati
Sponsors
Medical School of Hannover
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Provision of written informed consent prior to enrolment. Patients have to be deemed captable of providing informed consent. - Men and women age >= 18 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients who aren´t deemed captable of providing informed consent. - Meeting the criteria for any other (than schizophrenia) ICD-10 diagnosis not in full remission, concomitant organic mental disorder or mental retardation. - Patients with substance abuse or dependence. - Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others. - Evidence of clinical relevant disease (e.g. renal or hepatic impairment, significant coronary artery disease, cerebro-vascular disease, viral hepatitis B or C, acquired immunodeficient syndrome (AIDS) or cancer), or a clinical finding, that, in the opinion of the investigator would be negatively affected by the study medication or that would affect the study medication. - ECG considered to showing clinically significant abnormality at enrolment - A thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrolment, whether or not the subject is being treated for hypothyroidism. - Administration of a depot injection within 1 dosing interval (for the depot) before week 0. - Use of antipsychotic, mood stabilizer, antidepressant, anxiolytic, hypnotic, or other psychoactive drugs within 48 hours before week 0 and throughout the study period (except medications specified in the protocol!). - Use of drugs that induce or inhibit the metabolizing cytochrome 3A4 enzymes within 2 weeks prior week 0 - Participation in another drug trial within 3 months prior to enrolment into the study. - Hypersensibility against Quetiapine or another component of the compound - Previous participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Changes of verbal memory processes (see protocol page 7);Secondary Objective: Evaluation of attentional deficits by acquisition of the following parameters: immediate memory (List Learning, Story Memory), visual perception (Figure Copy, Line Orientation), speech (Picture Naming, Semantic Fluency), attention (Digit Span, Coding) (see protocol page 7);Primary end point(s): Last visit of the 15th subject undergoing the trial | — |
Countries
Germany
Outcome results
None listed