schizophrenia (295.10, 295.20, 295.30, 295.90 according to Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
Conditions
Interventions
Trade Name: Seroquel
Product Name: Seroquel (Quetiapine)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: QUETIAPINE
CAS Number: 111974697
Concentration unit: mg milligram(s)
Concentration
Sponsors
University of Wuerzburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. A diagnosis of a schizophrenic illness (295.10, 295.20, 295.30, 295.90) by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) 3. Females and males aged 18-50 years 4. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment 5. Able to understand and comply with the requirements of the study 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. Pregnancy or lactation 2. Any DSM-IV Axis I disorder not defined in the inclusion criteria 3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others 4. Known intolerance or lack of response to quetiapine fumarate or Fluanxol®, as judged by the investigator 5. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir 6. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids 7. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation 8. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria 9. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment 10. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment 11. Unstable or inadequately treated medical illness (e.g. Congestive Heart Failure / CHF, angina pectoris, hypertension) as judged by the investigator 12. Involvement in the planning and conduct of the study 13. Previous enrolment or randomisation of treatment in the present study. 14. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements 15. Current pre-treatment with atypical antipsychotics within 3 months prior to study onset 16. Exogenous psychoses 17. Moderate, severe, or profound mental retardation 18. An absolute neutrophil count (ANC) of ?1.5 x 109 per liter 19. Unstable Diabetes Mellitus / HBA1C; patient with Diabetes Mellitus (DM) fulfilling one of the following criteria: ? Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) >8.5% ? Admitted to hospital for treatment of DM or DM related illness in past 12 weeks ? Not under physician care for DM ? Physician responsible for patient’s DM care has not indicated that patient’s DM is controlled ? Physician responsible for patient’s DM care has not approved patient’s participation in the study ? Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomization. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks ? Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Amplitude of the ERN/Ne, determined as the absolute negative peak voltage within an interval of 15-150 ms after incorrect response in individual average waveform;Secondary Objective: To determine the influence of Seroquel and Fluanxol on negative and positive symptomatology as well as cognitive functions in schizophrenic illnesses.;Primary end point(s): Monitoring of ACC activation via the ERN/Ne as a neurophysiological marker of frontal lobe function under treatment with Seroquel® compared to a typical antipsychotic drug (Fluanxol®) in a group of schizophrenic patients. | — |
Countries
Germany
Outcome results
None listed