Efficacy and safety of quetiapine in treating affective symptoms of patients with first-episode psychosis - a pilot study

• Conditions: Schizophrenia

• Registration Number: EUCTR2005-005839-10-DE
• Lead Sponsor: Georg-August-University Göttingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-23
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

·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 < 7 points
·Female patients who are pregnant, lactating or at risk of pregnancy
·history of idiopathic orthostatic hypotension, or condition that would predispose to (dehydration, hypovolaemia)
·Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B and C, via blood or other body fluids
·history of non-compliance as judged by the investigator
·Patients with substance dependence. A urine drug screen will be performed. The investigator will evaluate the results along with medical history to determine if the patient meets the DSM-IV criteria for substance dependence
·Patients with known diabetes mellitus or impaired glucose tolerance, especially a patient with Diabetes Mellitus (DM), glycosylated hemoglobin (HbA1c)>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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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