Patients have to fulfill the diagnostic criteria of a schizophrenia according to DSM-IV.
Conditions
Interventions
Trade Name: Seroquel 25
Product Name: Seroquel 25
Pharmaceutical Form: Capsule*
INN or Proposed INN: Quetiapine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Sponsors
Klinikum Fulda gAG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of schizophrenia by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) • Paranoid Type (295.30) • Catatonic Type (295.20) • Disorganized Type (295.10) • Undifferentiated Type (295.90) • Residual Type (295.60) 2. Females and males aged 18-55 years 3. Clinical indication for a new treatment with antipsychotics (in case of an acute phase) or an adaptation or change of antipsychotic medication (due to an instable course) 4. PANSS score at entry > 60 5. 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 6. Written informed consent 7. Capability to understand and comply with the requirements of the study 8. Patients without any medication affecting (serotonergic, dopaminergic and noradrenergic neurotransmission) 9. Patients with antipsychotic and / or antidepressive pre-treatment can be enrolled after a wash out period of 7 days. In case of fluoxetine at least 4 weeks 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. Any DSM-IV Axis I disorder not defined in the inclusion criteria 2. Predominantly organic psychosis 3. Any medical disease which will be related to psychopathology of the patient or will interfere with treatment requirements 4. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria 5. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment 6. Treatment with drugs affecting (serotonergic, dopaminergic and noradrenergic neurotransmission), especially neuroleptics, antidepressants, sedatives 7. Patients who had suffered from colzapine-induced agranulocytosis, or who had been treated with clozapine during two months prior to enrolement 8. Pregnancy or lactation 9. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others 10. Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator 11. 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 12. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids 13. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation 14. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment 15. Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator 16. Involvement in the planning and conduct of the study 17. Previous enrolment or randomisation of treatment in the present study. 18. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to examine, whether the application of quetiapine does result in significant changes of the major serotonergic metabolite 5-hydroxyindoleacetic acid (5-HIAA). ;Secondary Objective: Secondary objectives of the trail are: 1. To examine the relative concentrations of quetiapine in cerebrospinal fluid (CSF) vs plasma, and on the plasma/CSF. 2. To examine the role of the MDR1-polymorphism on the concentrations of quetiapine and 5-HIAA and HVA in CSF. 3. To examine the relative concentrations of neuropeptides e.g. neuropeptide Y (NPY) and corticotropin releasing factor (CRF). 4. To examine the relationship between D2 and 5-HT2A occupancy and CSF kinetics of quetiapine, biochemical parameters (5-HIAA and HVA) and clinical improvement. 5. To examine the effect of quetiapine on an improvement of clinical signs of schizophrenia (as measured by PANSS and CGI- ratings).;Primary end point(s): The objective of this study is to demonstrate a relationship between modifications of the cerebrospinal fluid (CSF) concentrations of 5-hydroxyindoleacetic acid (5-HIAA) and homovanillic acid (HVA) induced by quetiapine and the clinical response in patients after a chronic quetiapine treatment, taking into account the plasma and CSF concentrations of the quetiapine. Thus, the hypothesis is that changes of 5-HIAA and HVA in CSF induced by quetiapine (measured at baseline and after treatment) will significantly predict the degree of symptom improvement following a 4 week quetiapine treatment (i.e. decrease in PANSS total score). Because the reduction of dopaminergic neurotransmission by neuroleptics in general and also by quetiapine is supposed to be the predominant neurobiologic action for clinical response the primary variable assessed in this study is the level of HVA at baseline and after quetiapine treatment (4 weeks) in CSF. HVA will be analyzed from CSF-collections obtained at baseline and after the end of the treatment. | — |
Countries
Germany
Outcome results
None listed