Schizophrenia
Conditions
Interventions
Product Name: Seroquel
Pharmaceutical Form: Tablet
INN or Proposed INN: Quetiapinhemifumarat
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Product Name: Ser
Sponsors
Georg-August-University Göttingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · male and female patients with first-episode schizophrenia (based on ICD-10 criteria) · in- and out-patients · age between 18 and 45 · verbal IQ ³ 85 · given written informed consent 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: ·Other Psychiatric disorders not in full remission, concomitant organic mental disorder or mental retardation ·Patients who, in the investigator´s judgement, pose an imminent risk of suicide or a danger to self or others ·Hamilton Depression Rating Scale 8.5% ·ECG considered to show clinical significant abnormalities at enrolment as determined by a cardiologist ·A thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range and the laboratory used for sample analysis at enrolment, whether or not the subject is being treated for hypothyroidism ·Use of drugs that induce or inhibit the hepatic metabolizing cytochrome 3A4 enzyme within 2 weeks prior to randomization (e.g. inducers: phenytoin, carbamazepine, phenobarbital, rifampicin, rifabutin, glucocorticoids, thioridazine and St. Johns´wort (= Johanniskraut) and inhibitors: ketokonazole (except for topical use), itraconazole, fluconazole, erythromycin, clarithromycin, fluvoxamine, nefazodone, troleandomycin, indinavir, nelfinavir and saquinavir). ·Any serious and unstable somatic illness (e.g. malignant tumor, severe cardiovascular disease, etc.) that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect study medication. If relevant medical findings are obtained during the examination, it is at the physician’s discretion to initiate additional examinations (e.g. lab testing, ECG). If medically indicated examinations have already been carried out, the results should not be older than two weeks at the time of the screening visit. The patient can only participate in the study if all study results are within the normal range or the examiner has determined a deviation as clinically irrelevant. This should be clearly documented in the CRF. ·Participation in another drug trial within 4 weeks prior to enrolment into this study or longer in accordance with local requirements ·patients with insufficient knowledge of the German language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate whether a treatment with quetiapine for six months in patients with first-episode psychosis may be effective in treating depressive symptoms. ;Secondary Objective: The secondary objective of the study is to investigate whether a treatment with quetiapine for six months in patients with first-episode psychosis may be effective in mania-like symptoms and to evaluate the general efficacy in psychopathology as well as the safety and tolerability of quetiapine. A possible effect of a treatment with quetiapine will be evaluated on a clinical level.;Primary end point(s): Changes in the Hamilton Depression Rating Scale (HAMDS) from Baseline to Endpoint | — |
Countries
Germany
Outcome results
None listed