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

Klinikum Fulda gAG0 sites22 target enrollmentJanuary 2, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients have to fulfill the diagnostic criteria of a schizophrenia according to DSM-IV.
Sponsor: Klinikum Fulda gAG
Enrollment: 22
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

January 2, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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