Multicenter study of neurotransmitters and neuropeptides in schizophrenia: A multidisciplinary study of biological, pharmacokinetic, receptor occupancy and clinical relationships in patients suffering from schizophrenia treated with quetiapine (Seroquel®). - Quetiapine-Study

Conditions: Patients have to fulfill the diagnostic criteria of a schizophrenia according to DSM-IV.

Registration Number: EUCTR2006-002342-11-DE

Lead Sponsor: Klinikum Fulda gAG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 22

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

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